Bimekizumab

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. 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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