RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Orphan Drug (KR), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (JP)

Structure/Sequence

Sequence Code 143497H

Source: *****

Sequence Code 13007433L

Source: *****

155

Clinical Trials associated with Canakinumab

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 General Hospital Corp.

[+3]

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 Date28 Feb 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT06038526

/ RecruitingPhase 2IIT

Molecular Studies of Canakinumab in High-Risk Former-Smokers (CANIFS)

This phase II trial tests the impact of canakinumab on biologic samples (buccal, nasal, and blood) from former smokers with increased risk of cancer. Canakinumab blocks the activity of a protein called interleukin-1 beta (IL-1b), an agent of the inflammatory system and is used for the treatment of different non-cancer diseases (like auto-inflammatory diseases). Giving canakinumab may block the inflammatory system and could have positive effects to reduce cancer growth.

Start Date11 Mar 2024

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

100 Clinical Results associated with Canakinumab

100 Translational Medicine associated with Canakinumab

100 Patents (Medical) associated with Canakinumab

1,109

Literatures (Medical) associated with Canakinumab

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 Apr 2025·Current Research in Translational Medicine

Trends in drug repurposing: Advancing cardiovascular disease management in geriatric populations

Review

Author: Moka, Murali Krishna ; D K, Sriram ; Rathakrishnan, Deepalaxmi ; Jagadeeshwaran, V ; George, Melvin

Drug repurposing is a promising strategy for managing cardiovascular disease (CVD) in geriatric populations, offering efficient and cost-effective solutions. CVDs are prevalent across all age groups, with a significant increase in prevalence among geriatric populations. The middle-age period (40-65 years) is critical due to factors like obesity, sedentary lifestyle, and psychosocial stress. In individuals aged 65 and older, the incidence of CVDs is highest due to age-related physiological changes and prolonged exposure to risk factors. In this review we find that certain drugs, such as non-cardiovascular drugs like anakinra, probenecid, N-acetyl cysteine, quercetin, resveratrol, rapamycin, colchicine, bisphosphonates, hydroxychloroquine, SGLT-2i drugs, GLP-1Ras drugs and sildenafil are recommended for drug repurposing to achieve cardiovascular benefits in geriatric patients. However, agents such as canakinumab, methotrexate, ivermectin, erythromycin, capecitabine, carglumic acid, chloroquine, and furosemide are constrained in their therapeutic use and warrant meticulous consideration, rendering them less favorable for this specific application. This review emphasizes the importance of exploring alternative therapeutic strategies to improve outcomes in geriatric populations and suggests drug repurposing as a promising avenue to enhance treatment efficacy.

01 Mar 2025·JACC. Advances

Associations of Serum Urate and Cardiovascular Events in a Clinical Trial of Interleukin-1β Blockade

Article

Author: MacFadyen, Jean G ; Libby, Peter ; Adamstein, Nicholas H ; Ridker, Paul M ; Solomon, Daniel H ; Weber, Brittany N

BACKGROUND:

Serum urate (SU) associates with cardiovascular (CV) events, mortality, and gout.

OBJECTIVES:

The purpose of this study was to assess whether SU predicts CV risk in a trial of interleukin (IL)-1β inhibition with canakinumab, and whether IL-1β blockade, kidney function, or gout alter these associations.

METHODS:

This study is a subanalysis of the Canakinumab Antiinflammatory Thrombosis Outcome Study (CANTOS), which randomized 10,061 patients with prior myocardial infarction and elevated high-sensitivity C-reactive protein to 3 doses of canakinumab or placebo. SU was measured at baseline. Cox proportional hazards models compared major adverse cardiovascular events (MACE), CV death, and all-cause mortality among those with SU ≤6.8 mg/dL (normal), 6.8 to 9.0 mg/dL (elevated), and ≥9.0 mg/dL (markedly elevated). Cox regressions were repeated within subgroups, including canakinumab vs placebo, estimated glomerular filtration rate ≥60 vs <60 mL/min, and gout vs no gout.

RESULTS:

Markedly elevated SU associated with MACE (HR: 1.66 [95% CI: 1.38-1.99]; P < 0.0001), CV death (HR: 2.52 [95% CI: 1.98-3.21]; P < 0.0001), and all-cause mortality (HR: 2.43 [95% CI: 2.01-2.94]; P < 0.0001) compared to normal SU. After multivariable adjustment for a minimal set of potential confounders, SU independently predicted all 3 endpoints. Associations were unchanged after IL-1β blockade with canakinumab. For normal estimated glomerular filtration rate, SU associated with CV and all-cause mortality, but not MACE. Participants with gout had higher event rates independent of SU.

CONCLUSIONS:

In over 10,000 patients with coronary artery disease, individuals with markedly elevated SU have elevated CV risk despite aggressive treatment. IL-1β blockade did not modify these associations. Baseline kidney function and monosodium urate deposition may function as effect modifiers.

News (Medical) associated with Canakinumab

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

22 Jul 2024

·healthcare-digital.com

Research Breakthrough Promises New Lupus Treatments

The purple ribbon denotes World Lupus Day, May 10. As study of patients with lupus uncovers a root cause of the condition we take a deeper look at the autoimmune disease and how it is currently treated A study of patients with lupus has uncovered a root cause of the disease that may eventually lead to new treatments, researchers reported in a study published in Nature. The immune disorder affects more than 1.5 million people in the US alone, and damages skin, joints, the kidneys, the brain and other organs. Comparing blood samples from 19 patients suffering from lupus with healthy people, researchers found that the patients had an imbalance in immune-system cells called ‘T cells’. There was reduced production of T cells that aid in healing, and increased production of T cells that produce autoantibodies to attack healthy cells. In the wake of the study, we take a look at lupus – at its effects and the available treatments. What is lupus? Lupus is an autoimmune disease that causes the body's immune system to attack its own tissues and organs. This condition can affect various parts of the body, including skin, joints, kidneys, brain, heart and lungs. Diagnosis can be complex, as symptoms often mimic those of other ailments. Treatment options for lupus depend on the severity of symptoms and which organs are affected. The cause of lupus remains unknown, but researchers believe it involves a combination of genetic and environmental factors. Women are more likely to develop lupus than men, and it is more prevalent in certain ethnic groups. Patients with lupus are advised to protect themselves from sun exposure, as ultraviolet light can trigger flares in some individuals. How is lupus treated? Medications include anti-inflammatory drugs, antimalarial drugs and immunosuppressants. Research has shown antimalarial drugs such as hydroxychloroquine and chloroquine can decrease the frequency and severity of lupus flare-ups. They work by modulating the immune system, which is overactive in lupus patients. This helps reduce inflammation and pain, particularly in the skin and joints. These medications also help protect the heart, and are thought to lower the risk of blood clots in lupus patients. This is significant as individuals with lupus have an increased risk of cardiovascular complications. Antimalarials are used in combination with immunosuppressants for more severe cases. Immunosuppressants are used to treat lupus because the condition results in the body's immune system mistakenly attacking healthy tissue, causing inflammation and damage to organs including the kidneys, heart and lungs. Common immunosuppressants used in lupus treatment include methotrexate, azathioprine, mycophenolate mofetil, and cyclophosphamide. These can be administered orally or intravenously, depending on the specific drug and the patient's condition. The use of immunosuppressants carries risks, as a suppressed immune system makes the patient more susceptible to infections. Companies that specialise in lupus medicines Medications used to treat lupus include anti-inflammatory drugs, antimalarial drugs and immunosuppressants. The following are among the companies that produce treatments in these three categories. Immunosuppressants GlaxoSmithKline : Benlysta (based on belimumab) AstraZeneca : Saphnelo (anifrolumab-fnia) Aurinia Pharmaceuticals: Lupkynis (voclosporin) Roche : Rituxan (rituximab) Bristol Myers Squibb : Orencia (abatacept) Eli Lilly : Olumiant (baricitinib) Pfizer : Xeljanz (tofacitinib) Antimalarials Sanofi : Plaquenil (hydroxychloroquine) Anti-inflammatories Novartis : Ilaris (canakinumab) Janssen Pharmaceuticals: Remicade (infliximab) UCB: Cimzia (certolizumab pegol)

ImmunotherapyDrug Approval

13 Jun 2024

·www.prnewswire.com

Protalix BioTherapeutics to Host In-Person Investor Day to Discuss Current Treatment Landscapes and Clinical Results for Fabry Disease and Uncontrolled Gout

Event will take place on Wednesday, June 26, 2024 in New York CARMIEL, Israel, June 13, 2024 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell based protein expression system, today announced that it will host an in-person investor day at the Lotte Palace New York Hotel in New York on Wednesday, June 26, 2024 at 8:30 a.m. Eastern Daylight Time (EDT). The investor day will feature presentations by the following key opinion leaders: Aleš Linhart, DSc, FESC (Charles University, Prague), who will discuss the treatment landscape for Fabry disease and perspectives on Elfabrio® (pegunigalsidase alfa), a plant cell-expressed PEGylated recombinant α-Galactosidase-A enzyme approved for adult patients with Fabry disease. Naomi Schlesinger, MD (University of Utah), who will discuss the current treatment landscape for uncontrolled gout and top-line results from the First-in-Human Phase I single ascending dose clinical trial of PRX-115, a plant cell-expressed recombinant PEGylated uricase. In addition, the event will include a corporate overview and strategy presentation by Dror Bashan, Protalix's President and Chief Executive Officer. A live question and answer session will follow the formal presentations. To register for the event, please click here. About Aleš Linhart, DSc, FESC Aleš Linhart, DSc, FESC is currently heading the Department of Cardiovascular Medicine of the First Medical Faculty and General University in Prague, Czech Republic and serves as vice-dean for international affairs of the First Faculty of Medicine of Charles University in Prague. He obtained his MD degree at Charles University in Prague, received his training in cardiology and vascular medicine at General University Hospital in Prague and Broussais Hospital in Paris, France. In 2004 he was appointed professor at Charles University in Prague. His research focuses mainly on Fabry disease, metabolic cardiomyopathies, noninvasive cardiac imaging, and atherosclerosis. He is member of several scientific societies, namely Czech and European Society of Cardiology (ESC). He served as the chairman of the Working Group on Myocardial and Pericardial Diseases of the ESC and is the immediate past president of the Czech Society of Cardiology. He authored or co-authored more than 450 scientific peer-reviewed papers, 85 book chapters, and three monographs. About Naomi Schlesinger, MD Naomi Schlesinger, MD is the Harold J, Ardella T, and Helen T Stevenson Presidential Endowed Chair of Rheumatology, Professor and Chief Division of Rheumatology, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT. She is a previous Chief of the Division of Rheumatology at Rutgers-Robert Wood Johnson Medical School and Director of Rutgers Robert Wood Johnson Medical School Gout Center. Dr. Schlesinger is a previous President of the NJ Rheumatology Association and current President of the Utah Rheumatology Association and was the recipient of the 2015 Rheumatologist of The Year award by the Arthritis Foundation - NJ Chapter. Dr. Schlesinger is a noted authority in the field of gout, having published many papers regarding the diagnosis, treatment, and better understanding of the pathogenesis of gout. Dr. Schlesinger's research has won recognition, including the work titled: Efficacy of canakinumab (ACZ885), a fully human anti-Interleukin (IL)-1beta monoclonal antibody, in the prevention of flares in gout patients initiating allopurinol therapy, which was selected as one of the five highest-ranking abstracts that will likely shape our treatment paradigms for years to come in the 2010 ACR/ ARHP Annual Scientific Meeting and the work titled: Erectile dysfunction is common among gout patients, which was selected (one of 13) for inclusion in the official 2014 EULAR Press Conference from over 4000 abstracts. Other pioneering work includes the treatment of gout flares with topical ice, seasonality of gout, diagnosing gout using ultrasound, understanding the pathogenesis of bone erosions in gout, and the importance of anti-inflammatory treatment in gout. Dr. Schlesinger serves as the American College of Rheumatology (ACR) abstract Co-Chair on metabolic and crystal arthropathies, a member of the ACR Global Engagement Special Committee (GESC), and a member of the ACR Annual Meeting Planning Committee (AMPC). She is a Co-Director of the International Gout and Hyperuricemia Center, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. She serves as a consultant to pharmaceutical companies in the field of gout. About Protalix BioTherapeutics, Inc. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, was approved by both the FDA and the European Medicines Agency in May 2023. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX-115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; PRX-119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others. Investor Contact Mike Moyer, Managing Director LifeSci Advisors 617 308 4306 [email protected] Logo: SOURCE Protalix BioTherapeutics, Inc.

Phase 1Drug Approval

100 Deals associated with Canakinumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09315	Canakinumab	L04AC08	DB06168

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Gout	US	Novartis Pharmaceuticals Corp.	25 Aug 2023
Neonatal-Onset Multisystem Inflammatory Disease	AU	Novartis Pharmaceuticals Australia Pty Ltd.	10 May 2010
Systemic onset juvenile chronic arthritis	AU	Novartis Pharmaceuticals Australia Pty Ltd.	10 May 2010
Arthritis, Gouty	EU	Novartis Europharm Ltd.	23 Oct 2009
Arthritis, Gouty	IS	Novartis Europharm Ltd.	23 Oct 2009
Arthritis, Gouty	LI	Novartis Europharm Ltd.	23 Oct 2009
Arthritis, Gouty	NO	Novartis Europharm Ltd.	23 Oct 2009
Familial Mediterranean Fever	EU	Novartis Europharm Ltd.	23 Oct 2009
Familial Mediterranean Fever	IS	Novartis Europharm Ltd.	23 Oct 2009
Familial Mediterranean Fever	LI	Novartis Europharm Ltd.	23 Oct 2009
Familial Mediterranean Fever	NO	Novartis Europharm Ltd.	23 Oct 2009
Juvenile Idiopathic Arthritis	EU	Novartis Europharm Ltd.	23 Oct 2009
Juvenile Idiopathic Arthritis	IS	Novartis Europharm Ltd.	23 Oct 2009
Juvenile Idiopathic Arthritis	LI	Novartis Europharm Ltd.	23 Oct 2009
Juvenile Idiopathic Arthritis	NO	Novartis Europharm Ltd.	23 Oct 2009
Mevalonate Kinase Deficiency	EU	Novartis Europharm Ltd.	23 Oct 2009
Mevalonate Kinase Deficiency	IS	Novartis Europharm Ltd.	23 Oct 2009
Mevalonate Kinase Deficiency	LI	Novartis Europharm Ltd.	23 Oct 2009
Mevalonate Kinase Deficiency	NO	Novartis Europharm Ltd.	23 Oct 2009
Periodic Fever Syndrome	EU	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	EU	Novartis Europharm Ltd.	-
Lung Cancer	Phase 3	IT	Novartis Pharmaceuticals Corp.	03 Feb 2022
COVID-19	Phase 3	US	Novartis Pharmaceuticals Corp.	30 Apr 2020
COVID-19	Phase 3	FR	Novartis Pharmaceuticals Corp.	30 Apr 2020
COVID-19	Phase 3	IT	Novartis Pharmaceuticals Corp.	30 Apr 2020
COVID-19	Phase 3	RU	Novartis Pharmaceuticals Corp.	30 Apr 2020
COVID-19	Phase 3	ES	Novartis Pharmaceuticals Corp.	30 Apr 2020
COVID-19	Phase 3	GB	Novartis Pharmaceuticals Corp.	30 Apr 2020
Cytokine Release Syndrome	Phase 3	US	Novartis Pharmaceuticals Corp.	30 Apr 2020
Cytokine Release Syndrome	Phase 3	FR	Novartis Pharmaceuticals Corp.	30 Apr 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03064854 (Pubmed \| BMC Cancer) Manual	Phase 1	metastatic non-small cell lung cancer First line	-	Spartalizumab 300 mg Q3W + Gemcitabine/Cisplatin	lscdhttmwx(afvewwurns) = tbxilhfahj fkoqrugakc (vhafuwjhvr ) View more	Positive	24 Oct 2024
				Spartalizumab 300 mg Q3W + Pemetrexed/Cisplatin	lscdhttmwx(afvewwurns) = lbfpjtdbmf fkoqrugakc (vhafuwjhvr ) View more
EULAR 12024 \| EULAR 22024 Manual	Not Applicable	Systemic onset juvenile chronic arthritis	20	Canakinumab	gvdptqzmhz(inrsdagcxh) = ikkpuvvhsk evauokloec (ghknxbzewz ) View more	Positive	12 Jun 2024
EULAR2024	Not Applicable	Autoinflammatory disease interleukin-1β (IL-1β)	96	CANAKINUMAB (Familial Mediterranean Fever (FMF))	otlbabtyxu(ychweqpilw) = nlabymybuo oyoltnpjsj (dktutyzoum, 18.2) View more	-	05 Jun 2024
				CANAKINUMAB (Tumor Necrosis Factor Receptor-associated Periodic Syndrome (TRAPS))	otlbabtyxu(ychweqpilw) = mdtmykowsm oyoltnpjsj (dktutyzoum, 18.2) View more
EULAR2024	Not Applicable	Systemic onset juvenile chronic arthritis First line	79	Canakinumab as first biologic	yzgjadhyzf(ljdmtrjqel) = xbyocnqtum cloyyqctdn (acbgcpvkvg )	Positive	05 Jun 2024
				Canakinumab as second biologic	yzgjadhyzf(ljdmtrjqel) = qwcpxbutpq cloyyqctdn (acbgcpvkvg )
EULAR2024	Phase 4	Gout	12	Pegloticase + MTX	jbqwdcbntq(gylvryepea) = No new gout flares were reported in any patient receiving canakinumab prophylaxis. All active gout flares resolved within 48 hours of administration iymrhcgglm (mjtogptyjs ) 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	adtezjcpzq(vzmuhvyltp) = 95% of patients in the canakinumab group and in 98% of patients in the placebo group experienced any-grade AEs cikbncrffq (csjdzucopp ) 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	yldljzmlhc(ckkfmkjphr) = uvjledavjz qfepeevbio (bvqtgkbcjm )	Positive	01 Feb 2024
NCT03631199 (CANOPY-1, Pubmed) Manual	Phase 3	Non-Small Cell Lung Cancer Add-on \| First line C-reactive protein \| IL-6	643	Canakinumabpembrolizumab	ncednkmmjn(zgubsivsrp) = xuvdegawpd wrtbthbygv (nmpmqftujn ) View more	Negative	10 Jan 2024
				Placebopembrolizumab	ncednkmmjn(zgubsivsrp) = qrdyzkvczl wrtbthbygv (nmpmqftujn ) View more
NCT04239157 (ASH2023)	Phase 2	Chronic Myelomonocytic Leukemia \| Myelodysplastic Syndromes	27	Canakinumab 300 mg	yhueuxgfcf(vlzvroofay) = gmgxqghwtp jbbqphsexy (ndqgymscug )	-	09 Dec 2023
Can-Prevent-Lung (WCLC2023) Manual	Phase 2	Lung Cancer Canakinumab	15	Canakinumab	lxsqzciivw(zfsrvkcrtt) = grade 2 neutropenia (n= 4) leading to treatment disruption or discontinuation (no active infection) aoclqjilgo (owgbdklmgv ) View more	Positive	10 Sep 2023
				control group

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