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Approval is supported by data from the two Phase 3 studies, BE HEARD I and BE HEARD II, in which bimekizumab-bkzx improved the signs and symptoms of disease vs. placebo at Week 16, which were sustained to Week 48
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Hidradenitis suppurativa is a chronic, painful and potentially debilitating inflammatory skin disease
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The milestone marks the fifth indication for bimekizumab-bkzx in the U.S., underscoring UCB’s commitment to raising standards of care across a range of IL-17 mediated diseases
Brussels (Belgium), November 20, 2024 – 07:00 (CET) – Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).1 Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A).1
“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,” said investigator and lead author of the studies, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston, MA, U.S. “In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”
Hidradenitis suppurativa is a chronic, recurring, painful and potentially debilitating inflammatory skin disease.2,3 The main symptoms are nodules, abscesses and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin and buttocks.2,3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.2,3
“We are working toward a world where people with hidradenitis suppurativa live without stigma, feel widely understood and are treated effectively. Today’s approval of bimekizumab-bkzx is an exciting time for the hidradenitis suppurativa community, offering a new possibility for the treatment of people in the U.S. living with moderate to severe disease,” said Brindley Brooks, Founder and Executive Director, HS Connect, U.S.
The approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bimekizumab-bkzx in the treatment of adults with moderate to severe HS.4 Results showed that a higher proportion of patients treated with bimekizumab-bkzx vs. placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials.4 Bimekizumab-bkzx treatment also resulted in clinically meaningful improvements in the key ranked secondary endpoint, HiSCR75, vs. placebo at Week 16.4 Clinical responses were sustained to Week 48.4 The safety profile of bimekizumab-bkzx was consistent with safety data seen in previous trials across indications with no new safety signals.4 Detailed results from BE HEARD I and BE HEARD II have been published in The Lancet.4
“We are thrilled that with this milestone BIMZELX is now FDA-approved for the treatment of adults with moderate to severe hidradenitis suppurativa, a chronic and painful disease affecting approximately one in 100 people. This is the fifth patient population who may benefit from BIMZELX in the U.S., representing a significant step forward in our mission to alleviate the global burden of immune-mediated inflammatory diseases,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer, UCB. “This progress underscores our commitment to addressing unmet needs in hidradenitis suppurativa and other immunological conditions, delivering innovative medicines and raising standards of care.”
This FDA approval of bimekizumab-bkzx for the treatment of adults with moderate to severe hidradenitis suppurativa follows its recent approvals for the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis.1 Bimekizumab-bkzx was first approved in the U.S. in October 2023, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1
About BE HEARD I and BE HEARD II
BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 studies designed to evaluate the efficacy and safety of bimekizumab-bkzx in adults with moderate to severe hidradenitis suppurativa (HS).4 The two studies had a combined enrolment of 1,014 participants with a diagnosis of moderate to severe HS.4 The primary endpoint in both studies was HiSCR50 at Week 16.4 Secondary endpoints included HiSCR75 and HS-specific skin pain response at Week 16.1,4 HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.4 Detailed results from these studies are published in The Lancet.4
About BIMZELX® (bimekizumab-bkzx) in the U.S.
Bimekizumab-bkzx is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.1
Please see Important Safety Information below and full U.S. Prescribing Information at
http://www.ucb-usa.com/Innovation/Products/BIMZELX.
About BIMZELX®▼(bimekizumab) in the European Union (EU)/European Economic Area (EEA)
The approved indications for bimekizumab▼ in the EU are:5
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Plaque psoriasis: Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
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Psoriatic arthritis: Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
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Axial spondyloarthritis: Bimekizumab is indicated for the treatment of adults with active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP), and/or magnetic resonance imaging (MRI), who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
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Hidradenitis suppurativa: Bimekizumab is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy.
The label information may differ in other countries where approved. Please check local Prescribing Information.
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 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: @UCB_news.
References
1.BIMZELX® (bimekizumab) U.S. Prescribing Information. https://www.ucb-usa.com/Innovation/Products/BIMZELX. Accessed: November 2024.
2.Jemec GB. Clinical practice: hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-64.
3.Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1):18.
4.Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48 week, randomised, double blind, placebo controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-19.
5.BIMZELX® (bimekizumab) EU SmPC. Available at: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Accessed: November 2024.