Psoriasis is a chronic inflammatory condition driven by a complex interplay between heritable and microenvironmental factors. Genome-wide heritability for psoriasis (PsO) is estimated at up to 50%. Although bearing genetic susceptibility at birth, most patients will remain disease free for years until an exposomal trigger activates the immunological pathway that leads to the first disease flare. In rare patients, the first flare is an isolated event, but in most patients it will evolve into a chronically relapsing-remitting disease characterized by lasting lesions and recurrent flares. Primary objective is to compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA, at week 16 and week 24.
Patients will be randomized 1:1 to receive either 320mg bimekizumab at weeks 0 (W0), W4, W8 and W12, or clobetasol ointment for 2 to 4 weeks until complete clearance of the lesion. After a maximum of 4 weeks topical clobetasol will be applied twice weekly on the site of lesion until week 16 then stopped. Patients will not receive active treatment between week 16-24. Between week 24-96 patients that flare can receive continuous topical clobetasol if needed. These patients will be considered non-responders at subsequent timepoints for the main analysis. If the patients worsen their psoriasis under the treatments given during the study and progress to moderate or severe psoriasis (PASI 10 and above) they will end their participation to the study to receive a treatment adapted to the new severity of their psoriasis. The patients will be referred to their dermatologist to receive the actual standard of care adapted to their new condition.
During the study, the following assessments will be performed and samples will be collected

Start Date01 Apr 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Nice

NCT06786936

/ Not yet recruitingNot ApplicableIIT

Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms

The investigators seek clinically actionable understanding of the mechanisms that underlie depression in the context of immune mediated inflammatory diseases (IMIDs), delivered by a focused immune intervention study examining brain circuitry using state of the art imaging in the context of exquisitely specific therapeutic immune interception in human immune disease.
Glutamate concentration in the NAcc will be positively correlated with the magnitude of the inflammatory response and will be attenuated by IL-17A inhibition. Ultimately, this will be associated with an improvement in depressive symptoms.
The strength of coupling between early and late systems will be attenuated in the context of IL-17A-driven inflammation and will be correlated with less frequent switching behaviour following negative outcomes and ultimately depressive symptoms. This coupling will be re-established following IL-17 antagonism.
Patients whose depressive symptoms benefit most from IL-17A antagonism will exhibit greatest resting-state and task-specific functional connectivity between Th-NAcc.

Start Date28 Feb 2025

Sponsor / Collaborator

NHS Greater Glasgow & Clyde

[+2]

NCT06668181

/ Not yet recruitingPhase 3

Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.

Start Date01 Dec 2024

Sponsor / Collaborator

UCB Biopharma SRL

100 Clinical Results associated with Bimekizumab

100 Translational Medicine associated with Bimekizumab

100 Patents (Medical) associated with Bimekizumab

285

Literatures (Medical) associated with Bimekizumab

01 Feb 2025·LANCET

Review

Author: Sabat, Robert ; Garg, Amit ; Szepietowski, Jacek C ; Wolk, Kerstin ; Alavi, Afsaneh ; McGrath, Barry ; Wortsman, Ximena

Hidradenitis suppurativa is a chronic inflammatory disease characterised by painful, deep-seated nodules, abscesses, and draining tunnels in the skin of axillary, inguinal, genitoanal, or inframammary areas. In recent years, the body of knowledge in hidradenitis suppurativa has advanced greatly. This disorder typically starts in the second or third decade of life. The average worldwide prevalence is 1% but varies geographically. Hidradenitis suppurativa has a profound negative effect on patients' quality of life and on the gross value added to society. Comorbidities (eg, metabolic syndrome, inflammatory arthritis, and inflammatory bowel disease) frequently accompany skin alterations, because of systemic inflammation. Pathogenesis of hidradenitis suppurativa is complex and includes innate immune mechanisms (eg, macrophages, neutrophils, IL-1β, tumour necrosis factor [TNF], and granulocyte colony-stimulating factor), T-cell mechanisms (eg, IL-17 and IFN-γ), and B-cell mechanisms (eg, associated with dermal tertiary lymphatic structures and autoantibodies). Chronic inflammation leads to irreversible skin damage with tunnel formation and morbid scarring. Current treatment includes drug therapy (for the initial, purely inflammatory phase), combined drug and surgical therapy (for the destructive phase), or surgery alone (for the burnout phase). The first systemic therapies approved for hidradenitis suppurativa targeting TNF (adalimumab) and IL-17 (secukinumab and bimekizumab) have expanded drug therapy options for moderate-to-severe disease, which were previously mainly restricted to oral antibiotics. Moreover, there is a robust pipeline of immunomodulatory drugs in various stages of development for hidradenitis suppurativa. Aims of management should include early intervention to prevent irreversible skin damage, adequate control of symptoms including pain, and mitigation of extra-cutaneous comorbidities, all requiring early diagnosis and an interdisciplinary, holistic and personalised approach.

01 Feb 2025·Actas Dermo-Sifiliograficas

Safety and Efficacy Profile of Bimekizumab in Patients With Psoriasis and Psoriatic Arthritis: An 18-Patient Case Series

Article

Author: Martorell, A ; Melgosa Ramos, F J ; Ortiz Salvador, J M ; Melgosa Ramos, FJ ; Mansilla Polo, M ; Ortiz Salvador, JM

01 Feb 2025·Actas Dermo-Sifiliograficas

Article

Author: M, Mansilla Polo ; Martorell, A ; Melgosa Ramos, F J ; Ortiz Salvador, J M ; Melgosa Ramos, FJ ; Mansilla Polo, M ; Ortiz Salvador, JM

101

News (Medical) associated with Bimekizumab

16 Jan 2025

·www.prnewswire.com

UCB Announces U.S. Availability of 320 mg/2 mL Single-Injection Administration Option for BIMZELX® (bimekizumab-bkzx)

BIMZELX® (bimekizumab-bkzx) is now commercially available by prescription in the United States in a 2 mL prefilled syringe and autoinjector, each containing 320 mg of BIMZELX The single-injection device offers convenience for patients requiring a 320 mg dose of BIMZELX with single-injection administration ATLANTA, Jan. 16, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, announced today that a single-injection 2 mL prefilled syringe and autoinjector, each containing 320 mg of BIMZELX® (bimekizumab-bkzx) is now available. These are in addition to the currently available 1 mL device administration options, each containing 160 mg of BIMZELX. With the new presentations, patients requiring a 320 mg dose of BIMZELX will have options for single-injection administration.1 "With five new FDA-approved indications for BIMZELX in just over a year, we've had the opportunity to reach a wider range of people living with chronic inflammatory conditions who have long been in need of new treatment options," said Camille Lee, Head of U.S. Immunology, UCB. "With the addition of a single-injection administration regimen, we are further expanding options and enhancing the treatment experience for individuals with moderate-to-severe plaque psoriasis, active psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis, and moderate-to-severe hidradenitis suppurativa who receive a 320 mg dose of BIMZELX." The approval of the 320 mg single-injection administration option in October 2024 was supported by data from studies evaluating the bioequivalence of BIMZELX 320 mg given as one 2 mL subcutaneous injection, and BIMZELX 320 mg given as two 1 mL subcutaneous injections, in healthy study participants.1 In the U.S., the indications for BIMZELX where a 320 mg dose is recommended are adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis (PsA) with coexistent moderate-to-severe plaque psoriasis, and adults with moderate-to-severe hidradenitis suppurativa.1* In all other indications, adults with active PsA, adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS), a 160 mg dose is recommended.1 Through BIMZELX Navigate®, UCB offers tailored patient support to patients who have been prescribed BIMZELX. Upon enrollment, patients will be offered support from a dedicated Nurse Navigator. This licensed, registered nurse will be available to discuss treatment goals, provide training assistance to patients on how to administer BIMZELX, connect eligible patients to copay support, and keep patients up-to-date about their BIMZELX shipment and insurance coverage status. Patients who have been prescribed BIMZELX may enroll in BIMZELX Navigate at . UCB is actively engaging in access conversations with payers, with a focus on our patient value strategy and keeping the patient at the center of these discussions. Based on these conversations, we are progressing well toward our goal to enable access to our medicines for people who need them, in a way that is sustainable for patients, society, and UCB. Full affordability information can be found at ucb-usa.com/Sustainability/Affordability/Bimzelx-Pricing-Info and . For additional medical information, patient assistance or any other information, please call UCBCares® at 1-844-599-CARE (2273) or visit askucbcares.com. Notes to Editors: About BIMZELX® (bimekizumab-bkzx) BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.1 IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.1, 2-4 IL-17F is over-expressed in skin and highly elevated in the serum of patients with PSO, PsA, nr-axSpA, AS, and HS.1, 2-5 The approved indications for BIMZELX in the U.S. are:1 Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa *The recommended dosage of BIMZELX in patients is as follows: Plaque Psoriasis: Administer 320 mg by subcutaneous injection at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg or more, consider a dose of 320 mg every 4 weeks after Week 16. Psoriatic Arthritis: Administer 160 mg by subcutaneous injection every 4 weeks. For patients with coexisting moderate-to-severe plaque psoriasis, use the dosage and administration for plaque psoriasis. Non-Radiographic Axial Spondyloarthritis: Administer 160 mg by subcutaneous injection every 4 weeks. Ankylosing Spondylitis: Administer 160 mg by subcutaneous injection every 4 weeks. Hidradenitis Suppurativa: Administer 320 mg by subcutaneous injection at Weeks 0, 2, 4, 6, 8, 10, 12, 14 and 16, then every 4 weeks thereafter. See full prescribing information for recommendations regarding missed doses, preparation and administration instructions. Please see Important Safety Information below and full U.S. Prescribing Information at . BIMZELX U.S. IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION Suicidal Ideation and Behavior BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment. Infections BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment. Liver Biochemical Abnormalities Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis. Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs. Immunizations Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX. Most Common Adverse Reactions Most common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections. Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections. Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection. For further information, contact UCB: Investor Relations Antje Witte T +32.2.559.94.14 email [email protected] Brand Communications Nicole Herga T +1.773.960.5349 email [email protected] About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. Forward looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. References BIMZELX® (bimekizumab-bkzx) U.S. Prescribing Information. . Accessed January 2025. Glatt S, Baeten D, Baker T et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77:523–32. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487-498. Rumberger BE, Boarder EL, Owens SL, et al. Transcriptomic analysis of hidradenitis suppurativa skin suggests roles for multiple inflammatory pathways in disease pathogenesis. Inflamm Res. 2020;69(10):967-973. US-BK-2401977 Date of preparation: January 2025 BIMZELX®, UCBCares®, and BIMZELX Navigate® are registered trademarks of the UCB Group of Companies. ©2025 UCB, Inc., Smyrna, GA 30080. All rights reserved. SOURCE UCB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical Result

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

25 Nov 2024

·www.drugs.com

FDA Approves Bimzelx for Hidradenitis Suppurativa

MONDAY, Nov. 25, 2024 -- The U.S. Food and Drug Administration has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa . Bimzelx becomes the first and only approved medicine designed to selectively inhibit interleukin 17F in addition to interleukin 17A and is the fifth indication for Bimzelx in the United States. The approval is supported by data from two phase 3 studies of adults with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II). Compared with placebo, results showed that a higher proportion of patients treated with Bimzelx achieved ≥50 percent improvement in signs and symptoms of hidradenitis suppurativa at week 16, which was the primary end point as measured by Hidradenitis Suppurativa Clinical Response (HiSCR50). Bimzelx treatment also resulted in clinically meaningful improvements in the secondary end point, HiSCR75 at week 16, compared with placebo. Clinical responses were sustained to week 48, with no new safety signals reported. "The approval of Bimzelx in moderate-to-severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today," BE HEARD investigator Alexa B. Kimball, M.D., from the Beth Israel Deaconess Medical Center in Boston, said in a statement. Approval of Bimzelx was granted to UCB. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Bimekizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11550	Bimekizumab	-	DB12917

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hidradenitis Suppurativa	EU	UCB Pharma SA	30 Apr 2024
Hidradenitis Suppurativa	IS	UCB Pharma SA	30 Apr 2024
Hidradenitis Suppurativa	LI	UCB Pharma SA	30 Apr 2024
Hidradenitis Suppurativa	NO	UCB Pharma SA	30 Apr 2024
Ankylosing Spondylitis	EU	UCB Pharma SA	15 Jun 2023
Ankylosing Spondylitis	IS	UCB Pharma SA	15 Jun 2023
Ankylosing Spondylitis	LI	UCB Pharma SA	15 Jun 2023
Ankylosing Spondylitis	NO	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	EU	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	IS	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	LI	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	NO	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	EU	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	IS	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	LI	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	NO	UCB Pharma SA	15 Jun 2023
Erythrodermic psoriasis	JP	UCB Japan Co. Ltd.	20 Jan 2022
Psoriasis vulgaris	JP	UCB Japan Co. Ltd.	20 Jan 2022
Pustular psoriasis	JP	UCB Japan Co. Ltd.	20 Jan 2022
Arthritis, Psoriatic	EU	UCB Pharma SA	20 Aug 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Enthesitis-Related Arthritis	Phase 3	-	UCB Biopharma SRL	01 Feb 2025
Juvenile Idiopathic Arthritis	Phase 3	-	UCB Biopharma SRL	01 Feb 2025
Chronic large plaque psoriasis	Phase 3	US	UCB Biopharma SRL	20 Dec 2018
Chronic large plaque psoriasis	Phase 3	CA	UCB Biopharma SRL	20 Dec 2018
Rheumatoid Arthritis	Phase 2	CZ	UCB Celltech	01 Apr 2015
Rheumatoid Arthritis	Phase 2	HU	UCB Celltech	01 Apr 2015
Rheumatoid Arthritis	Phase 2	MD	UCB Celltech	01 Apr 2015
Rheumatoid Arthritis	Phase 2	PL	UCB Celltech	01 Apr 2015
Rheumatoid Arthritis	Phase 2	RU	UCB Celltech	01 Apr 2015
Rheumatoid Arthritis	Phase 2	SK	UCB Celltech	01 Apr 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04242446 (BE HEARD I, CTgov)	Phase 3	Hidradenitis Suppurativa	505	placebo (Placebo)	sojvnkkglc(cavxodexqb) = qhbzofzcan czoghmcmcm (offabnsvau, uzyonrtjoq - swnfkvfqax) View more	-	09 Jan 2025
				BKZ (BKZ Dosing Regimen 1)	sojvnkkglc(cavxodexqb) = thukdrcyhx czoghmcmcm (offabnsvau, edvmzvejqd - wjtheysbhz) View more
BE AGILE (Pubmed \| RMD Open)	Phase 2	Ankylosing Spondylitis \| Axial Spondyloarthritis	-	Bimekizumab 160 mg every 4 weeks	luafidcets(hnaxakzxxz) = qvuavfupvd vvkscbsgmv (ojzqmsndtl ) View more	Positive	01 Jan 2025
NCT03598790 (BE BRIGHT, CTgov)	Phase 3	Plaque psoriasis	1,353	BKZ (Cohort A: BKZ 320 mg Q8W)	wvmdykxusw(ryicxkmqpy) = rklljvaqlm nqsfkhmdre (dhhrhzhcum, zmiabbipso - gydvamfpyh) View more	-	06 Dec 2024
				BKZ (Cohort A: BKZ 320 mg Q4W)	wvmdykxusw(ryicxkmqpy) = skizawkiix nqsfkhmdre (dhhrhzhcum, spabcrqefq - yfasnklmje) View more
NCT04242498 (BE HEARD II, CTgov)	Phase 3	Hidradenitis Suppurativa	509	placebo (Placebo)	xqamjgkolg(olgydvfthn) = lvmiuksczv ocatuqlxhw (alcuwouins, ssrvdshujl - fltthfrdrl) View more	-	05 Dec 2024
				BKZ (BKZ Dosing Regimen 1)	xqamjgkolg(olgydvfthn) = txbtnpxpax ocatuqlxhw (alcuwouins, ppibkrpsxf - yyqldehcnd) View more
Pubmed \| Ann Rheum Dis	Not Applicable	Axial Spondyloarthritis	-	Bimekizumab 160 mg	jjmabkcrwf(nqdeeswclo) = sewrnztead xrshwpyqns (ziybfqeaja )	-	01 Dec 2024
				Placebo	jjmabkcrwf(nqdeeswclo) = sdvtrrztbr xrshwpyqns (ziybfqeaja )
NCT03412747 \| NCT03370133 \| NCT03536884 \| NCT03410992 \| NCT03598790 (BE VIVID \| BE READY \| BE SURE \| BE BRIGHT \| BE RADIANT, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	-	1,107	Bimekizumab	kwwrmtsiwx(rieymrluer) = ndtywnblps fmskrkhqpk (mazzswgrfa ) View more	Positive	01 Dec 2024
NCT03928704 (BE MOBILE 1, CTgov)	Phase 3	Non-radiographic axial spondyloarthritis	274	Placebo (Placebo (up to Week 16) (Global Population))	otrewprjfh(xpuxnrttnz) = bfgubpqszk chfqazbbvi (koabjdqntv, dkfvsdvdyo - mcfakqcgqa) View more	-	13 Nov 2024
				Bimekizumab (Bimekizumab 160 mg Q4W (up to Week 16) (Global Population))	otrewprjfh(xpuxnrttnz) = qsloatbhqe chfqazbbvi (koabjdqntv, wffhhyogqq - yicyedjaib) View more
NCT03355573 (BE AGILE \| OLE \| BE AGILE 2, CTgov)	Phase 2	Ankylosing Spondylitis	255	Bimekizumab	wngcnlxtsu(eijhndnvpa) = ftbuhsvcot xadtaftmaa (whseklubfp, djodixipuz - zqtacvwfot) View more	-	13 Nov 2024
NCT03895203 (BE OPTIMAL, CTgov)	Phase 3	Arthritis, Psoriatic	852	Placebo+Bimekizumab	egrrwqobmp(lcwynkxgoh) = xpbvwnazel bnfodevddv (dqumvxnhpt, qpltectgfy - errezlwkuv) View more	-	23 Oct 2024
NCT03896581 (BE COMPLETE, CTgov)	Phase 3	Arthritis, Psoriatic	400	Placebo	twzcunelju(cdtktdqdqu) = uouhsbqwgu hmzahquveg (lafaqbgtmf, eocvjaijmp - ypbonltqeg) View more	-	16 Oct 2024

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