UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
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| [18-October-2023] |
ATLANTA, Oct. 18, 2023 /PRNewswire/ -- Regulated Information – Inside Information – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1 BIMZELX is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).1 The approval of BIMZELX is supported by data from three Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials (BE READY, BE VIVID, and BE SURE), which evaluated the efficacy and safety of BIMZELX in 1,480 adults with moderate-to-severe plaque psoriasis.2,3,4
“Today’s FDA approval for BIMZELX is an exciting milestone that reflects our commitment to continuously improving the standard of care in plaque psoriasis and to raising expectations of what treatment can deliver. We know that completely clear skin is valued by people with psoriasis and, in our Phase 3 trials, at week 16, 85-91% of patients treated with BIMZELX achieved clear or almost clear skin, with 59-68% achieving the goal of complete clearance,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. “With BIMZELX now approved for psoriasis, we will move forward rapidly to submit applications for additional indications in the U.S.” “We have been eagerly awaiting bimekizumab, the first IL-17A and IL-17F inhibitor, to be approved in the U.S. for the treatment of adults with moderate-to-severe plaque psoriasis. In Phase 3/3b trials, bimekizumab achieved superior levels of skin clearance at week 16 compared to placebo and three existing biologics for psoriasis, with responses being rapid and lasting up to a year. Long-term data have also shown that the majority of patients maintained high levels of clinical response through three years,” said Mark Lebwohl, MD, bimekizumab investigator, Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and Chairman Emeritus, Kimberly and Eric J. Waldman Department of Dermatology. Psoriasis affects more than 7.5 million adults in the U.S. and impacts much more than the skin itself.5 In addition to the recognized skin symptoms such as itching and flaking, psoriasis can place strains on patients and their families, impacting work, relationships and home lives.6,7 A U.S. observational study (n=846) reported that only one in four patients achieved self-assessed complete skin clearance after six months of treatment with biologics highlighting the burden of plaque psoriasis and the need for additional new treatment options.8 The FDA recommended dosage of BIMZELX for psoriasis patients is 320 mg (given as two subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.1 For patients weighing ≥120 kg, a dose of 320 mg every 4 weeks after week 16 may be considered.1 BIMZELX may be administered by a healthcare professional, or a patient may self-inject after proper training.1 BIMZELX is available as an autoinjector and a pre-filled syringe.1 BIMZELX will be available in the U.S. in approximately one month. “The approval of bimekizumab will provide an important new treatment option for adults living with moderate-to-severe plaque psoriasis,” said Leah McCormick Howard, J.D., President and CEO for the National Psoriasis Foundation. “Our hope is that new treatments translate into improved outcomes for many and help alleviate the physical and emotional burden of psoriasis.” Jean-Christophe Tellier, CEO, UCB added, “We are pleased to deliver new options for people living with severe diseases as part of an unprecedented series of product launches from UCB around the world. Delivering these solutions draws on our scientific expertise and understanding of disease biology and our legacy of deep understanding of patients to provide differentiated treatments. Our continued work embodies what UCB stands for – that we are inspired by patients, driven by science.” Additional information about BIMZELX, including the full prescribing information, is available at UCB-USA.com/Innovation/Products/BIMZELX. For additional medical information, patient assistance or any other information, please call UCBCares® at 1-844-599-CARE (2273) or visit askucbcares.com. UCB’s goal is to enable affordable access to our medicines for all people who need them, in a way which is sustainable for patients, society and UCB. Full affordability information can be found at UCB-USA.com/Sustainability/Affordability/Bimzelx-Pricing-Info and http://www.BIMZELX.com. Key Findings from the Phase 3 Clinical Development Program Patients treated with BIMZELX achieved superior levels of skin clearance at week 16, compared to those who received ustekinumab (ranked secondary endpoint, BE VIVID; p<0.0001), placebo (co-primary endpoint, BE READY and BE VIVID; p<0.0001) and adalimumab (co-primary endpoint, BE SURE; p<0.001), as measured by at least a 90 percent improvement in the Psoriasis Area & Severity Index (PASI 90) and an Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1).2,3,4 Ranked secondary endpoints included PASI 75 at week 4 and PASI 100 (complete skin clearance) at week 16.2,3,4 Key findings across all studies include:
The most common adverse reactions (≥ 1%) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.1 Notes to Editors: Dr. Lebwohl is an investigator for UCB. He has not accepted any consulting payments from UCB. About BIMZELX (bimekizumab-bkzx) Please see Important Safety Information below and full U.S. prescribing information at UCB-USA.com/Innovation/Products/BIMZELX and http://www.BIMZELX.com. BIMZELX U.S. IMPORTANT SAFETY INFORMATION IMPORTANT SAFETY INFORMATION Infections Tuberculosis Liver Biochemical Abnormalities Inflammatory Bowel Disease Immunizations Most Common Adverse Reactions For further information, contact UCB: Investor Relations U.S. Communications About UCB UCB, Brussels, Belgium (www.ucb.com), 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 8,700 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. 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SOURCE UCB | ||
Company Codes: EuronextBrussels:UCB, OTC-PINK:UCBJY |
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