RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China)

Structure/Sequence

Sequence Code 143497H

Source: *****

Sequence Code 13007433L

Source: *****

142

Clinical Trials associated with Canakinumab

NCT06838143

/ Not yet recruitingNot Applicable

Real Life Non-interventional Study on Safety and Effectiveness of Ilaris® (Canakinumab) 150 mg for Subcutaneous Injection in Hereditary Periodic Fever Syndrome (CAPS, crFMF, TRAPS and HIDS/MKD) Patients and sJIA Patients (REASSURE)

This is a study to evaluate safety and effectiveness of Ilaris in adult and pediatric patients receiving the drug in a clinical setting for any of the following indications, Hereditary Periodic Fever Syndromes, Cryopyrin-associated periodic syndromes (CAPS), colchicine resistance familial Mediterranean fever (crFMF), TNF receptor associated periodic syndrome (TRAPS), Hyper-IgD syndrome / Mevalonate kinase deficiency (HIDS/MKD) or Systemic juvenile idiopathic arthritis (sJIA).

Start Date30 Apr 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06691217

/ Not yet recruitingPhase 2IIT

Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis

The primary goal of this clinical trial is to test the hypothesis that the drug canakinumab (anti-IL-1B monoclonal antibody) decreases vascular inflammation when used by people with a history of coronary artery disease, including those with and without clonal hematopoiesis driven by mutations in TET2.

Start Date01 Apr 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+3]

CTIS2024-511241-19-00

/ Not yet recruitingPhase 1

- PDY18058

Start Date30 Jul 2024

Sponsor / Collaborator

Sanofi-Aventis Recherche et Développement SA

100 Clinical Results associated with Canakinumab

100 Translational Medicine associated with Canakinumab

100 Patents (Medical) associated with Canakinumab

987

Literatures (Medical) associated with Canakinumab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Canakinumab for the management of pyoderma gangrenosum: a case series of two patients and literature review

Review

Author: Lee, Senhong ; Lai, Francis Yi Xing ; Spratt, William ; Yang, Howard Jie

AIMS:

To evaluate the efficacy and adverse events of canakinumab in the treatment of pyoderma gangrenosum (PG).

METHODS:

We report two cases of refractory PG treated with canakinumab after failing multiple therapies.

RESULTS:

A 44-year-old female achieved complete ulcer resolution after 31 months of canakinumab but experienced recurrent infections, including pneumonia requiring intensive care unit (ICU) admission. A 49-year-old male showed no improvement and suffered recurrent Pseudomonas infections, leading to treatment cessation after nine months.

CONCLUSIONS:

We present a case series of two patients with PG on canakinumab therapy, both of whom experienced significant infections needing hospitalization. Further studies are needed to evaluate the efficacy and complication profile of canakinumab against other biologic therapy options.

01 Dec 2025·Current Pain and Headache Reports

Familial Mediterranean Fever (FMF): Emerging Concepts in Diagnosis, Pain Management, and Novel Treatment Options: A Narrative Review

Review

Author: Baptiste, Carlo Jean ; Norwood, Haley A ; Islam, Kazi N ; Nguyen, Ivan D ; Islam, Rahib K ; Ahmadzadeh, Shahab ; Kaye, Alan D ; Barrie, Sonnah ; McGregor, David W ; Robin, Connor J ; Parker-Actlis, Tomasina Q ; Shekoohi, Sahar

PURPOSE OF REVIEW:

Familial Mediterranean Fever (FMF) is a hereditary autoinflammatory disorder predominantly affecting individuals of Mediterranean and Middle Eastern descent, including those with certain heritages including Sephardic Jewish, Armenian, Turkish, and Arab. The disorder affects up to 1 in 200 people making it a very common etiology for pain states worldwide, including serositis mediated painful states of the chest, joint, and abdomen.

RECENT FINDINGS:

Defined by recurrent episodes of fever and inflammation, FMF can lead to not only severe pain, but complications such as renal amyloidosis, if untreated. This narrative review explores the genetic basis, clinical manifestations, diagnostic criteria, and current management strategies for FMF. Mutations in the MEFV gene result in the dysregulation of the pyrin inflammasome, leading to excessive production of inflammatory cytokines. Diagnosis primarily relies on clinical criteria supported by genetic testing. Colchicine remains the cornerstone of treatment, effectively preventing inflammatory attacks and complications. For colchicine-resistant patients, IL-1 antagonists like anakinra and canakinumab show promise, although their long-term benefits require further investigation. The present investigation underscores the importance of early diagnosis and integrated treatment approaches to improve patient outcomes, pain management, and quality of life.

01 Jun 2025·Lancet Rheumatology

First-line biological versus conventional synthetic disease-modifying antirheumatic drug therapy in adult-onset Still's disease: a multicentre, retrospective, propensity weighted cohort study

Article

Author: Klapa, Sebastian ; Krusche, Martin ; Feist, Eugen ; Petzinna, Simon Michael ; Blank, Norbert ; Keyßer, Gernot ; Schulz, Nils ; Filla, Tim ; Pfeil, Alexander ; Klemm, Philipp ; Schäfer, Valentin S ; Kernder, Anna ; Vordenbäumen, Stefan ; Ernst, Diana ; Henes, Jörg ; Friedrich, Rhea ; Rech, Jürgen ; Meinecke, Anna ; Pankow, Anne

BACKGROUND:

Data on the efficacy of biological disease-modifying antirheumatic drug (DMARD) therapies such as anakinra, canakinumab, and tocilizumab as a primary therapeutic option in adult-onset Still's disease (AOSD) are scarce, and treatment recommendations rely mainly on data extrapolated from paediatric studies. The aim of this study was to compare the effectiveness of first-line biological DMARD therapy versus conventional synthetic DMARD therapy in AOSD.

METHODS:

This multicentre, retrospective, propensity weighted cohort study was done at 16 secondary and tertiary rheumatology centres across Germany. Eligible patients were diagnosed with AOSD, met the Yamaguchi classification criteria, and had active disease without current treatment. All patients had documented follow-up assessments at weeks 12 and 72. The primary endpoint was sustained, event-free remission; a combined endpoint of sustained remission (C-reactive protein <10 mg/L and no arthritis, rash, or fever) and absence of complications during follow up in patients treated with first-line biological DMARDs (with or without glucocorticoids) or conventional synthetic DMARDs (methotrexate or glucocorticoids). Analysis was by propensity score weighted logistic regression, thereby balancing for the initial Pouchot score, ferritin concentration, and age and sex differences between groups. Analysis was done in the per protocol population. People with lived experience were not involved in the study design. The study is registered with the ISRCTN registry, ISRCTN86135778.

FINDINGS:

Between Jan 1, 2007, and Sep 30, 2022, we screened 228 patients for inclusion. 142 patients were excluded, and 86 patients with AOSD who had an incident diagnosis or a flare without any maintenance treatment including glucocorticoids were enrolled and included in our analysis. 50 (58%) of 86 patients were female, 36 (42%) were male, and 84 (98%) were White. The mean age at inclusion was 39·4 years (SD 15·4). 44 (51%) of 86 had received a first-line biological DMARD and 42 (49%) received a first-line conventional synthetic DMARD. Biological DMARD therapy was associated with a greater likelihood of reaching the primary endpoint of sustained, event-free remission (OR 7·20, 95% CI 2·50-36·64; p=0·0007). At week 72, the rate of sustained, event-free remission was 50% (95% CI 34-65%; n=21) in the first-line biological DMARD group and 12% (3-23%; n=5) in the first-line conventional synthetic group. Glucocorticoid-related complications were more often described in the first-line conventional synthetic DMARD group (new-onset arterial hypertension [n=2] and glucocorticoid-related skin diseases [n=3]) versus none in the first-line biological DMARD group). Three (7%) of 42 patients in the conventional synthetic DMARD group died (two from macrophage activation syndrome, one unknown cause) versus none in the first-line biological DMARD group.

INTERPRETATION:

First-line biological DMARD therapy in patients with AOSD showed a statistically significant association with sustained, event-free remission and fewer complications. Our findings highlight the potential of biologics to improve patient outcomes compared with conventional treatment options in AOSD.

FUNDING:

None.

News (Medical) associated with Canakinumab

28 May 2025

·www.einpresswire.com

Alvotech and Advanz Pharma Extend Strategic Partnership to Commercialize Three Additional Biosimilars in Europe

Advanz Pharma secures exclusive rights from Alvotech to commercialize three biosimilar candidates in Europe in addition to previously partnered programs The agreement includes proposed biosimilars to Ilaris ® (canakinumab), Kesimpta ® (ofatumumab) and an additional early-stage undisclosed biosimilar candidate REYKJAVIK, Iceland and LONDON, May 28, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have entered into an agreement to expand their commercial partnership to cover three additional biosimilar candidates. The new agreement covers the supply and commercialization in Europe of biosimilar candidates to Ilaris ® (canakinumab), a human antibody interleukin-1β blocker indicated for the treatment of various inflammatory diseases, and Kesimpta ® (ofatumumab), a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis, in addition to a third undisclosed biosimilar candidate. Alvotech will be responsible for development and commercial supply and Advanz Pharma will be responsible for registration and commercialization in Europe. The agreement includes development and commercial milestones for the three products, totaling up to US$180 million at current exchange rates (EUR 160 million). In addition, the partners will participate in a revenue share. "We are very pleased to expand our partnership with Advanz Pharma. We now have agreed to launch proposed biosimilars to more than ten reference products in Europe, starting in 2025 and reaching beyond 2030. This new agreement demonstrates the business development potential and value of Alvotech’s growing biosimilars pipeline, that is unrivalled by any other biosimilars developer,” said Róbert Wessman, chairman and CEO of Alvotech. “By adding canakinumab, ofatumumab and another early-stage program to our strategic partnership with Alvotech, Advanz Pharma now holds European commercial rights to proposed biosimilars referencing more than ten originator biologics. Importantly, two of these three new candidates address rare-disease indications, reinforcing our commitment to broaden access to rare disease and specialty medicines. Biosimilars are a cornerstone of our growth strategy and this expanded collaboration positions us to deliver sustainable value for patients and healthcare systems alike,” said Steffen Wagner, CEO, Advanz Pharma. Alvotech and Advanz Pharma previously entered into partnership agreements, signed in 2023, to commercialize proposed biosimilars to Xolair ® (omalizumab), Simponi ® (golimumab), Entyvio ® (vedolizumab), Eylea ® (aflibercept) and Eylea ® HD (aflibercept), Dupixent ® (dupilumab), Taltz ® (ixekizumab) and Tremfya ® (guselkumab). The supply and commercialization agreements cover all 30 member countries of the European Economic Area, as well as the UK and Switzerland. For omalizumab, the agreement additionally includes Canada, Australia, and New Zealand. According to IQVIA, the current addressable market for the proposed biosimilars covered by the partnership agreements between Alvotech and Advanz Pharma in the countries in scope is now at least US$13.8bn. Use of trademarks Simponi ® and Tremfya ® are registered trademarks of Johnson & Johnson Inc. Xolair ® , Ilaris ® and Kesimpta ® are registered trademarks of Novartis AG. Eylea ® is a registered trademark of Regeneron Pharmaceuticals, Inc. Entyvio ® is a registered trademark of Millennium Pharmaceuticals, Inc. Dupixent ® is a trademark and brand of Sanofi Biotechnology. Taltz ® is a registered trademark of Eli Lilly and Company. About Alvotech Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com . None of the information on the Alvotech website shall be deemed part of this press release. About Advanz Pharma Partner of choice in specialty, hospital, and rare disease medicines. Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialization partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialization of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity. Alvotech Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial or operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory review and interactions, the satisfactory responses to the FDA’s inspection findings and resolution of other deficiencies conveyed following the re-inspection of Alvotech’s manufacturing site, the potential approval, including for AVT02, AVT04, and the product candidates in scope of the partnership with Advanz, by the FDA and other regulatory agencies and commercial launch of its product candidates, the timing of the announcement of clinical study results, the commencement of patient studies, regulatory applications, approvals and market launches, and the estimated size of the total addressable market of Alvotech’s pipeline products. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to reach development milestones under commercial partnership agreements including the partnership with Advanz; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech’s estimates of expenses and profitability; (7) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners, including Advanz, to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements, including the partnership with Advanz; (15) Alvotech’s ability, and that of its commercial partners, including Advanz, to execute their commercialization strategy for approved products; (16) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (18) the potential impact of the ongoing COVID-19 pandemic on the FDA’s review timelines, including its ability to complete timely inspection of manufacturing sites; (19) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in Ukraine and global geopolitical tension, and the ongoing and evolving COVID-19 pandemic on the Alvotech’s business, financial position, strategy and anticipated milestones; and (20) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. Advanz Pharma Forward Looking Statements Certain statements in this press release are forward-looking statements. These statements may be identified by words such as “anticipate”, "expectation", "belief', "estimate", "plan", "target”, “project”, “will”, “may”, “should” or "forecast" and similar expressions, or by their context. Although ADVANZ believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz’s markets, and other factors beyond the control of Advanz. Neither ADVANZ nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice. MEDIA CONTACTS Alvotech Global Communications and Investor Relations Benedikt Stefansson alvotech.ir@alvotech.com Advanz Pharma Global Corporate Communications Courtney Baines Tel: +44 7776 516979 courtney.baines@advanzpharma.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

License out/inBiosimilar

19 Feb 2025

·www.biospace.com

5 Pharma Powerhouses Facing Massive Patent Cliffs—And What They’re Doing About It

iStock, photoschmidt Merck’s Keytruda may be the most talked about drug facing loss of exclusivity but it’s far from the only one, as several of the industry’s top-performers are losing key market protections. Some companies are more prepared than others. Biopharma is being battered by patent headwinds that are the strongest they’ve been in nearly 15 years. That’s according to a report last month from analyst firm William Blair, which estimates that from 2023 through the end of 2025, nearly 50 products will have lost patent protections—in turn eroding the aggregate sales of these drugs from $162.8 billion in 2025 to just $67 billion in 2029. “We believe the biggest headwind to large pharma revenue growth over the next five years is loss of exclusivity,” William Blair analysts wrote in the report. The patent cliff is exactly that: a cliff. Take AbbVie’s Humira, for instance. The immunology juggernaut is one of the most high-pro to go off patent in recent years after topping the list of pharma’s highest selling drugs for much of its blissful patent-protected period. AbbVie recorded sales of $21.24 billion in 2022. The year after, sales were $14.04 billion and last year just $8.99 billion. To patch the hole, AbbVie has leaned on its new immunology stars, Skyrizi and Rinvoq, which brought in $11.72 billion and $5.97 billion globally in 2024, respectively. Five industry powerhouses will see the same challenge in the coming years, as potential biosimilar and generic competition threaten sales. According to William Blair, the loss will affect assets that accounted for more than 30% of the collective revenues from Bristol Myers Squibb, Pfizer, AstraZeneca, Novartis and Regeneron in 2024. In this article, BioSpace looks at five pharma players—and one honorable mention—facing the greatest loss of sales in the coming years and how they’re planning to replace the revenue. Merck Set to Lose Exclusivity for Keytruda, Seminal PD-1 Inhibitor Assets at risk : Lenvima (2025), Januvia and Janumet (2026), Lynparza (2027), Gardasil/Gardasil 9 (2028) and Keytruda (2028) Perhaps the most talked about patent cliff belongs to Merck’s blockbuster cancer therapy Keytruda, one of the industry’s highest-earning assets with more than $29 billion in sales last year. Keytruda faces a key patent expiry in 2028. To help shore up the drug’s sales, Merck is gearing up for regulatory discussions about its subcutaneous formulation of the PD-1 blocker. If successful, the product’s launch could lessen the grade of the patent cliff the company inevitably faces. Aside from subcutaneous Keytruda, Merck is leaning on its pulmonary hypertension therapy Winrevair, which according to William Blair will be the pharma’s “main driver of growth,” expecting $4.9 billion in sales in 2029. Other Merck assets set to encounter patent headwinds in the coming years include the cancer drug Lenvima later this year, Gardasil/Gardasil 9 in 2028, the diabetes drugs Januvia and Janumet in 2026 and the cancer therapy Lynparza in 2027. Bristol Myers Squibb Cuts Costs and Jobs in Face of Three Impending Cliffs Assets at risk : Yervoy (2025), Eliquis (2026) and Opdivo (2028) As in the case of Regeneron, BMS is set to lose key protections for one its most valuable assets. Eliquis, an anticoagulant for the prevention of stroke, made over $13 billion in 2024. Ahead of the loss of exclusivity in 2026, several generics have already secured the FDA’s approval. These include copycats from Mylan Pharmaceuticals and Micro Labs Limited, which the FDA greenlit in December 2019 . BMS and its partner Pfizer have put up a strong legal effort to stall these generics, securing a critical court win in August 2020 that would let them keep the market to themselves until 2026. Still, the pressure is on for BMS to find alternative sources of revenue, especially because its cancer therapy Yervoy faces loss of exclusivity even sooner—this year. Yervoy brought in $2.5 billion for the pharma in 2024. According to William Blair, BMS is unprepared for the cliffs its facing, “despite several recent notable acquisitions, there is not much to get excited about in Bristol Myers’ late-stage pipeline,” the firm wrote. BMS’s most standout asset is the PD-1 blocker Opdivo, which likewise faces key expiries in 2028, though a recently approved subcutaneous formulation could help buoy growth through this point and beyond. Instead of beefing up its pipeline, BMS has chosen to weather the storm with cost-cuts. In April 2024, the pharma kicked off a sweeping realignment program —which includes around 2,200 layoffs—with an eye toward saving up to $1.5 billion through 2025. In its full-year 2024 business report earlier this month, the company tacked another $2 billion to the cost-cutting goal, which it hopes to realize through 2027. Eliquis Tops Pfizer’s List of Patent Problems Asset at risk : Prevnar (2026), Ibrance (2027), Xtandi (2027) and Eliquis (2028) Eliquis’ loss of exclusivity could be even more painful for Pfizer , the prospects of which William Blair called “bleak” in its report. In 2024, Eliquis emerged as Pfizer’s top-performing asset, growing 10% year-on-year operationally to bring in $7.4 billion . But the product faces loss of exclusivity in April 2028, with several generics waiting to eat into its sales. Compounding the company’s revenue problem is the fact that Eliquis was named among the first 10 drugs subject to price negotiations with the Centers for Medicare & Medicaid Services (CMS) prescribed by the Inflation Reduction Act (IRA), with the discounted negotiated price to go into effect in 2026. Pfizer has several other assets that are set to lose key patent protections in the coming years, too, including the pneumonia shot Prevnar in 2026 and the cancer drugs Ibrance and Xtandi, both in 2027. Erosion in sales is just one of Pfizer’s problems, which also include an activist investor jockeying for control and an unreliable COVID-19 market dynamics. There’s also what William Blair called an “underwhelming legacy pipeline.” Seemingly aware of its precarious position, Pfizer sought to shore up its bottom line with an aggressive and sweeping cost-cutting measure. The savings program announced in October 2023 was designed to help the company lower its spend by $3.5 billion last year, while a more recent round in May 2024 set a $1.7 billion savings target by the end of 2027. Aside from cost-cuts, the pharma is also banking on several 2025 catalysts—including up to four regulatory decisions—that could position the pharma for better growth in coming years, according to its fourth-quarter business report . Commercially, Pfizer is leaning heavily on its antibody-drug conjugate Padcev, which CEO Albert Bourla told investors was “an important growth driver.” The company is expecting additional data for Padcev later this year that could open a path for approval in muscle-invasive bladder cancer. If approved, that indication “would nearly triple the total addressable patients in the U.S.,” Bourla said. AstraZeneca’s Plan for Reaching $80B in Revenue Despite Expiries Asset at risk : Farxiga (2025), Soliris (2025) In May 2024, AstraZeneca unveiled an ambitious plan to deliver $80 billion in total annual revenue by 2030—a goal that could be crippled when Farxiga loses key patent protections later this year. In 2024, the drug brought in $7.7 billion , corresponding to 31% year-on-year growth at constant currencies. Soliris, a key rare disease asset that brought in nearly $2.6 billion in 2024, is also facing loss of exclusivity and is expected to face biosimilar challenge this year. Still, the pharma appears well-positioned to hit its 2030 target. As per William Blair, AstraZeneca has done a “commendable job” of building out its product portfolio, particularly in the oncology space. Enhertu, a Daiichi Sankyo-partnered antibody-drug conjugate (ADC), recently won broad approval in breast cancer. Enhertu will retain crucial patent protections past 2030, according to William Blair. Other cancer standouts include Tagrisso and Imfinzi, which respectively made $6.58 billion and $4.72 billion in 2024. AstraZeneca also boasts its clinical pipeline, which could bear fruit in the near-future. In a media call ahead for the pharma’s fourth-quarter earnings report, Chief Finance Officer Aradhana Sarin called 2025 an “unprecedented catalyst-rich period” for AstraZeneca. In particular, the company is awaiting key readouts for several of its products, including not only Enhertu and Imfinzi but also the recently approved Datroway and asthma treatment Fasenra. AstraZeneca is also expecting crucial data for new assets such as camizestrant for different cancers and baxdrostat for hypertension. “The value of our pipeline has been increasing, and now we have more than 90 late-stage studies underway, with an average peak-year revenue potential of over $1 billion,” Sarin said. Novartis Struggles to Maintain Entresto’s Exclusivity Assets at risk : Entresto (2025), Xolair (2025), Jakafi (2026), Cosentyx (2029) and Tafinlar (2030) Novartis ’ patent problems escalated in 2024. The heart failure drug Entresto, which made $7.8 billion last year, is set to lose market exclusivity in July 2025 . The pharma started efforts to guard its place in the market as early as September 2022, when it filed a citizen Pptition to the FDA asking the regulator not to approve drug applications referencing Entresto and specific patents related to it. But last July, the FDA denied the petition, noting that it is possible for generic drugs to sidestep Entresto’s patents with labeling tweaks. The same month, the FDA signed off on MSN Pharmaceuticals’ generic version of Entresto. Those decisions have since opened a legal saga for Novartis, which most recently secured a last-minute stay against MSN’s copycat, preventing its market entry while the pharma’s patent complaint remains open. In its fourth-quarter and full-year 2024 earnings call last month, company executives expressed confidence that Novartis would be able to smoothly weather Entresto’s loss of exclusivity in mid-2025. The company expects to “secure pediatric exclusivity” for Entresto, which could potentially help soften the blow of generics this year, CEO Vas Narasimhan said during the call. Aside from the heart failure drug, Novartis is also facing down patent expirations for Xolair in 2025, Jakafi in 2026, Cosentyx in 2029 and Tafinlar in 2030. Ilaris, indicated for auto-inflammatory diseases, lost key protections last year, while chronic myeloid leukemia drug Tasigna became open to generic erosion in 2023. Much of Novartis’ resilience through the patent expiries will come from fiscal discipline, Chief Financial Officer Harry Kirsch explained during the call. Honorable Mention: Regeneron’s High-Dose Eylea Not Making Up for LOE Asset at risk : Eylea (2024) Regeneron is already in the throes of a major patent expiry for its blockbuster eye disease drug Eylea, which in 2024 was the pharma’s top-performing asset with $5.97 billion in sales in the U.S. But last May, the company lost key protections for the drug, thereby opening it up to considerable copycat competition. And of these, there are several. The same month Eylea went off patent, the FDA signed off on two interchangeable biosimilars, Biocon Biologics’ Yesafili and Samsung Bioepis and Biogen’s Opuviz. A few months later, Novartis spinoff Sandoz also won the regulator’s go-ahead for its own biosimilar called Enzeevu. To help protect Eylea’s place in the market, Regeneron has taken many of its competitors to court. In December 2023, the pharma sued Samsung Bio for alleged patent infringement. Regeneron also has a case against Sandoz, seeking to block the generics developer from marketing its biosimilar. The pharma has also developed a high-dose (HD) version of Eylea to keep the product’s competitive edge. The product earned the FDA greenlight in August 2023, but uptake has been slow. In the fourth quarter of 2024, Eylea HD’s sales came in at $305 million, below analyst expectations of $336 million. In the pharma’s earnings call, CEO Leonard Schleifer urged investors to “look beyond” its Eylea franchise, noting that “our strategy is not to be solely dependent on any one thing.” In 2025, Regeneron is looking forward to the launch of its anti-IL-4/IL-13 antibody Dupixent in chronic obstructive pulmonary disease, as well as several key data readouts.

Drug ApprovalAcquisitionPatent InfringementPatent Expiration

21 Jan 2025

·www.globenewswire.com

Pharming to nominate biopharmaceutical leader Fabrice Chouraqui as new Executive Director and Chief Executive Officer

Leiden, the Netherlands, January 21, 2025: Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces today that the Board of Directors has nominated Fabrice Chouraqui to become Pharming’s new Executive Director and Chief Executive Officer, succeeding Sijmen de Vries. Pharming will nominate Mr. Chouraqui for the appointment as Executive Director and Chief Executive Officer for a term of four years at an upcoming Extraordinary General Meeting of Shareholders (EGM). Information regarding the EGM, including the notice to convene, will be shared shortly in a separate press release. Upon the appointment of Mr. Chouraqui, Sijmen de Vries will resign from the Board of Directors. To ensure a smooth hand-over of tasks and responsibilities, Mr. de Vries will remain a strategic advisor to the new CEO until December 31, 2025. Dr. Richard Peters, Chairman of the Board of Directors, commented:“After an extensive search, the Board and I are confident that Fabrice Chouraqui is the right candidate to lead Pharming and continue to implement our growth strategy, shaping Pharming into the rare disease company of choice. Fabrice is a deeply experienced global pharmaceutical and biotechnology executive, who brings a wealth of profound global expertise and experience, across the entire biopharmaceutical value chain, to Pharming. On behalf of the entire Board of Directors, I would like to thank Sijmen de Vries for his great commitment to Pharming over the past 16 years and for creating the company that it is today, serving patients and paving the way for delivery on the company’s strategy for growth. We are grateful that Sijmen will continue to be available through the end of the year to ensure a smooth hand-over with Fabrice.” Sijmen de Vries, Chief Executive Officer, commented:“I am very pleased with the nomination of Fabrice Chouraqui as my successor. Fabrice brings strong leadership experience with global pharmaceutical companies and highly innovative biotechnology companies to Pharming. To make way for Fabrice to take over the executive leadership of the Company, I will resign from the Board of Directors upon the appointment of Fabrice by our shareholders. I look forward to supporting Fabrice, working closely together through the remainder of the year, and ensuring a smooth hand-over.” Fabrice Chouraqui commented:“I am honored to have the opportunity to take over the leadership of Pharming, building on the strong foundation and joining at a time when I can help propel the company through its next stage of growth in the rare disease space. I am impressed by Pharming’s growing portfolio of products and commercial opportunities which will pave the way for us to become the rare disease company of choice.” ProfileMr. Fabrice Chouraqui (date of birth: August 1, 1970, French national, U.S. citizen) is a global pharmaceutical executive with a record of value creation at Flagship Pioneering, Novartis and Bristol-Myers Squibb. A purpose-driven leader with a passion for bringing innovative treatments to patients, Mr. Chouraqui has a reputation for building strong followership in organizations. He is scientifically minded, with a deep understanding across the business spectrum, from research and development to access and commercialization, including strong expertise in investor management and business development. Across his career, Mr. Chouraqui has led the launch of treatments in many therapeutic areas, including highly targeted specialty care drugs and large primary care medicines. He consistently demonstrates strategic and innovative thinking to achieve long-lasting results and has a strong record of developing next generation talents and highly diverse teams. Until recently, Mr. Chouraqui was a CEO-Partner at Flagship Pioneering, one of the largest Biotech Venture Capital firms in the US. Mr. Chouraqui also served as CEO of Cellarity, Inc., one of the companies created by Flagship Pioneering. In his CEO capacity, Mr. Chouraqui was leading the development of Cellarity, a company which is driving a radically new approach to drug discovery by working at the intersection of AI and biology. Mr. Chouraqui raised over $250M and attracted world-renowned investors. He initiated a collaboration with Novo Nordisk and had Cellarity recognized as a top biotech to watch by several sources. Today, Mr. Chouraqui holds the position of Executive Chairman at Cellarity. Prior to joining Flagship Pioneering, Mr. Chouraqui spent 10 years at Novartis. He was President of Novartis Pharmaceuticals USA from 2016 to 2019, during which he delivered strong growth despite negative price impact and significantly improved profitability. Promoted to turn around performance after the business suffered issues with recent launches, Mr. Chouraqui developed sophisticated commercial and access capabilities to meet the new market environment. He achieved strong market positions for two significant growth drivers (Cosentyx and Entresto), drove the uptake of the rare disease drug Ilaris, initiated the landmark PIONEER clinical trial in heart failure, and championed several business development initiatives. Mr. Chouraqui moved the organization’s culture from “consensus building, conservative and siloed” to “questioning, experimenting and collaborative.” He also served as Novartis representative on the board of BIO. Before leading the US organization, Mr. Chouraqui was President, Latin America & Canada (2014-2016) for Novartis Pharmaceuticals, responsible for leading a portfolio shift from established primary care medicines to innovative specialty care drugs. He also served as Global Head, Business Franchise Neuroscience (2012-2014). In this role, he relaunched Gilenya (Multiple Sclerosis) following a post-launch regulatory review and made Gilenya the largest growth contributor in the Novartis five-year strategic plan. Mr. Chouraqui also addressed late-stage pipeline gaps with the start of the siponimod program in Secondary Progressive Multiple Sclerosis (approved in 2019) and the identification of business development opportunities, which led to the in-licensing of ofatumumab in MS from GSK (launched as Kesimpta) and a partnership with Amgen on erenumab for migraine (launched as Aymovig). From 2000 to 2010, Mr. Chouraqui held multiple international roles at Bristol-Myers Squibb, ultimately serving as Vice President, Commercial Operations, Asia-Pacific and General Manager, Southeast Asia (2008-2010). He began his career in R&D roles at Roussel Uclaf and Hoechst Marion Roussel, pharmaceutical companies that were predecessors to today’s Sanofi. Mr. Chouraqui earned a MBA from INSEAD and a Doctorate in Pharmacy, a Post-Graduate Degree in Quality Assurance of Medicines, and a MSc in Biological and Medicinal Sciences from University of Paris V. Mr. Chouraqui shall have stepped down as Executive Chairman of Cellarity, Inc., a non-listed company, no later than upon his appointment as the new Executive Director and Chief Executive Officer of Pharming. Thereafter, Mr. Chouraqui intends to serve as a non-executive Board member of Cellarity. Mr. Chouraqui also holds the position of independent Board member of OranoMed, a non-listed (and therefore private) subsidiary of Orano Group. OranoMed is a company specialized in the research and development of Pb-212 based radioligand alpha therapies for the treatment of various types of cancers. The resume of Mr. Chouraqui is available on our website. For further public information, contact:Pharming Group, Leiden, the NetherlandsMichael Levitan, VP Investor Relations & Corporate CommunicationsT: +1 (908) 705 1696E: investor@pharming.com FTI Consulting, London, UKVictoria Foster Mitchell/Alex Shaw/Amy ByrneT: +44 203 727 1000 LifeSpring Life Sciences Communication, Amsterdam, the NetherlandsLeon MelensT: +31 6 53 81 64 27E: pharming@lifespring.nl About Pharming Group N.V. Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia-Pacific. For more information, visit www.pharming.com and find us on LinkedIn. Forward-Looking Statements   This press release may contain forward-looking statements. Forward-looking statements are statements of future expectations that are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in these statements. These forward-looking statements are identified by their use of terms and phrases such as “aim”, “ambition”, ‘‘anticipate’’, ‘‘believe’’, ‘‘could’’, ‘‘estimate’’, ‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’, “milestones”, ‘‘objectives’’, ‘‘outlook’’, ‘‘plan’’, ‘‘probably’’, ‘‘project’’, ‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’, ‘‘target’’, ‘‘will’’ and similar terms and phrases. Examples of forward-looking statements may include statements with respect to timing and progress of Pharming's preclinical studies and clinical trials of its product candidates, Pharming's clinical and commercial prospects, and Pharming's expectations regarding its projected working capital requirements and cash resources, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Pharming's clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory, commercial, competitive and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming's 2023 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming's actual results could differ materially and adversely from those anticipated or implied thereby. All forward-looking statements contained in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Readers should not place undue reliance on forward-looking statements. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release. Pharming does not undertake any obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information. Inside InformationThis press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. Attachments Fabrice Chouraqui Pharming to nominate new Executive Director and Chief Executive Officer_EN_21JAN25

Executive ChangeDrug Approval

100 Deals associated with Canakinumab

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KEGG	Wiki	ATC	Drug Bank
D09315	Canakinumab	L04AC08	DB06168

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Gout	United States	Novartis Pharmaceuticals Corp.	25 Aug 2023
Neonatal-Onset Multisystem Inflammatory Disease	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	10 May 2010
Systemic onset juvenile chronic arthritis	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	10 May 2010
Arthritis, Gouty	European Union	Novartis Europharm Ltd.	23 Oct 2009
Arthritis, Gouty	Iceland	Novartis Europharm Ltd.	23 Oct 2009
Arthritis, Gouty	Liechtenstein	Novartis Europharm Ltd.	23 Oct 2009
Arthritis, Gouty	Norway	Novartis Europharm Ltd.	23 Oct 2009
Familial Mediterranean Fever	European Union	Novartis Europharm Ltd.	23 Oct 2009
Familial Mediterranean Fever	Iceland	Novartis Europharm Ltd.	23 Oct 2009
Familial Mediterranean Fever	Liechtenstein	Novartis Europharm Ltd.	23 Oct 2009
Familial Mediterranean Fever	Norway	Novartis Europharm Ltd.	23 Oct 2009
Juvenile Idiopathic Arthritis	European Union	Novartis Europharm Ltd.	23 Oct 2009
Juvenile Idiopathic Arthritis	Iceland	Novartis Europharm Ltd.	23 Oct 2009
Juvenile Idiopathic Arthritis	Liechtenstein	Novartis Europharm Ltd.	23 Oct 2009
Juvenile Idiopathic Arthritis	Norway	Novartis Europharm Ltd.	23 Oct 2009
Mevalonate Kinase Deficiency	European Union	Novartis Europharm Ltd.	23 Oct 2009
Mevalonate Kinase Deficiency	Iceland	Novartis Europharm Ltd.	23 Oct 2009
Mevalonate Kinase Deficiency	Liechtenstein	Novartis Europharm Ltd.	23 Oct 2009
Mevalonate Kinase Deficiency	Norway	Novartis Europharm Ltd.	23 Oct 2009
Periodic Fever Syndrome	European Union	Novartis Europharm Ltd.	23 Oct 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Schnitzler Syndrome	NDA/BLA	European Union	Novartis Europharm Ltd.	-
Lung Cancer	Phase 3	Italy	Novartis Pharmaceuticals Corp.	03 Feb 2022
COVID-19	Phase 3	United States	Novartis Pharmaceuticals Corp.	30 Apr 2020
COVID-19	Phase 3	France	Novartis Pharmaceuticals Corp.	30 Apr 2020
COVID-19	Phase 3	Italy	Novartis Pharmaceuticals Corp.	30 Apr 2020
COVID-19	Phase 3	Russia	Novartis Pharmaceuticals Corp.	30 Apr 2020
COVID-19	Phase 3	Spain	Novartis Pharmaceuticals Corp.	30 Apr 2020
COVID-19	Phase 3	United Kingdom	Novartis Pharmaceuticals Corp.	30 Apr 2020
Cytokine Release Syndrome	Phase 3	United States	Novartis Pharmaceuticals Corp.	30 Apr 2020
Cytokine Release Syndrome	Phase 3	France	Novartis Pharmaceuticals Corp.	30 Apr 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04795466 (CTgov)	Phase 2	Alzheimer Disease \| Mild cognitive disorder	34	Canakinumab (Canakinumab)	yzhayxjweg(vpkaxwryva) = rvsddrovew zeeymrbrtj (yvsdtgvkds, 0.116) View more	-	06 May 2025
				Placebo (Placebo)	yzhayxjweg(vpkaxwryva) = rfwoikmvkx zeeymrbrtj (yvsdtgvkds, 0.0905) View more
NCT04581343 (PanCAN-SR1, CTgov)	Phase 1	Metastatic Pancreatic Cancer \| Metastatic Pancreatic Ductal Adenocarcinoma	10	Canakinumab	ccfxpbeuyr = kbbbbwwvhv xkuhexjdho (xrwwkvzwvg, vowtbobqqr - cnrhuzhnmg) View more	-	08 Apr 2025
NCT03775109 (ISAIAH, CTgov)	Phase 2	Hepatitis, Alcoholic	55	Canakinumab (Canakinumab)	oljvprtcuw = mtpszzpjlp ohxpgpsfdt (fmnoevttae, mnpakycauu - ywjradjthr) View more	-	11 Mar 2025
				Dextrose (Placebo)	oljvprtcuw = yamzosesme ohxpgpsfdt (fmnoevttae, tlcmyzfkmg - cngvmnkjkk) View more
NCT03064854 (Pubmed \| BMC Cancer) Manual	Phase 1	metastatic non-small cell lung cancer First line	-	Spartalizumab 300 mg Q3W + Gemcitabine/Cisplatin	fvlzzcxokf(bnxhzjpekr) = nyudfqkoeq ctkyxayyrt (rejnfsosfj ) View more	Positive	24 Oct 2024
				Spartalizumab 300 mg Q3W + Pemetrexed/Cisplatin	fvlzzcxokf(bnxhzjpekr) = fneteioeen ctkyxayyrt (rejnfsosfj ) View more
JPRN-jRCT2080222813 (EULAR 12024 \| EULAR 22024) Manual	Not Applicable	Systemic onset juvenile chronic arthritis	20	Canakinumab	ggvdrmxjmm(htuenuyyrx) = lqxqfnixdn qlrwnovjmb (wxraatbwvf ) View more	Positive	12 Jun 2024
EULAR2024	Not Applicable	Autoinflammatory disease interleukin-1β (IL-1β)	96	CANAKINUMAB (Familial Mediterranean Fever (FMF))	savglhnusu(cxhyiwuxyi) = hlfikciaqx cvhbhflpid (xfvbveogti, 18.2) View more	-	05 Jun 2024
				CANAKINUMAB (Tumor Necrosis Factor Receptor-associated Periodic Syndrome (TRAPS))	savglhnusu(cxhyiwuxyi) = batwjsaoaf cvhbhflpid (xfvbveogti, 18.2) View more
EULAR2024	Not Applicable	Systemic onset juvenile chronic arthritis First line	79	Canakinumab as first biologic	orbdzlzvcn(edsndjmnjh) = xmlkcmkuqx vipjlmlvau (orlsspbcbz )	Positive	05 Jun 2024
				Canakinumab as second biologic	orbdzlzvcn(edsndjmnjh) = tgdwrltbvs vipjlmlvau (orlsspbcbz )
EULAR2024	Phase 4	Gout	12	Pegloticase + MTX	gqzeaebofj(pazjjnvfcc) = No new gout flares were reported in any patient receiving canakinumab prophylaxis. All active gout flares resolved within 48 hours of administration sdwkumsmzz (kiltfnyjyk ) View more	Positive	05 Jun 2024
NCT03626545 (CANOPY-2, Pubmed \| Lung Cancer)	Phase 3	Advanced Lung Non-Small Cell Carcinoma circulating tumor DNA (ctDNA) \| C-reactive protein (CRP)	237	Canakinumab plus docetaxel	hjobjymkwt(aygeztygpq) = 95% of patients in the canakinumab group and in 98% of patients in the placebo group experienced any-grade AEs pdwmlmxlpv (wikiymkych ) View more	Negative	01 Mar 2024
				Placebo plus docetaxel
NCT02059291 (CLUSTER, Pubmed \| Arthritis Rheumatol)	Phase 3	Periodic Fever, Familial, Autosomal Dominant serum amyloid A protein (SAA)	53	Canakinumab 150 mg q4w	cuwoknefwb(xxhxfccvpw) = resgpvuyih cpplvqhqbm (lznldywexz )	Positive	01 Feb 2024

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