ATLANTA, GA — UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for BIMZELX® (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor, for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS). In addition, a second sBLA for the BIMZELX 2mL device presentations has also been accepted.
“We are excited to share progress on our FDA applications. The most recent sBLA seeks approval for BIMZELX in moderate-to-severe hidradenitis suppurativa, and is aligned to our goal of expanding the reach of BIMZELX to more patients living with IL-17–mediated diseases,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions, and Head of U.S., UCB. “In addition, the sBLA for the 2mL device presentations aims to offer increased convenience for patients. Today, one dose of BIMZELX in moderate-to-severe plaque psoriasis is administered as two 1mL injections. Approval of the 2mL device presentations would mean that patients would have an alternative one-injection regimen option.”
These new regulatory milestones represent two of five sBLAs accepted by the FDA for BIMZELX this year, following the previously announced applications in psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). BIMZELX was 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. BIMZELX is not approved in the U.S. for the treatment of moderate-to-severe HS, PsA, nr-axSpA, and AS, or for the 2mL device presentation. In the U.S., the efficacy and safety of BIMZELX in the treatment of moderate-to-severe HS, PsA, nr-axSpA, and AS have not been established and these are investigational indications.
The sBLA in moderate-to-severe HS is supported by data from the Phase 3 BE HEARD I and BE HEARD II studies where BIMZELX demonstrated clinically meaningful improvements in HiSCR50 vs. placebo at Week 16, the primary endpoint. A greater proportion of patients treated with BIMZELX vs. placebo also achieved HiSCR75 at Week 16, a key secondary endpoint. In addition, over 48 weeks, improvements increased for patients in these studies. The safety profile of BIMZELX was consistent with previous studies with no new safety signals observed.
The sBLA for the additional device presentations seeks approval of BIMZELX 2mL safety syringe and 2mL autoinjector with the aim of providing a second option to the currently approved 1mL presentations.
About Hidradenitis Suppurativa (HS)
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease. The main symptoms are nodules, abscesses, and pus-discharging tunnels (channels leading out of the skin), which typically occur in the armpits, groin, and buttocks. People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.
HS most commonly develops in early adulthood and affects approximately one percent of the population in most studied countries. Approximately one-third of people with HS have a family history of HS, and lifestyle factors such as smoking and obesity can also play a crucial role in the clinical course of HS.
The symptoms of pain, discharge, and scarring are not only a physical burden. People with HS also experience stigma: worrying about or directly experiencing negative attitudes and reactions from society in response to their symptoms. These feelings can lead to embarrassment, social isolation, low self-esteem, and sexual life impairment, and impact all areas of life, including interpersonal relationships, education, and work.
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 in adults with moderate-to-severe hidradenitis suppurativa (HS). The two studies had a combined enrollment of 1,014 participants with a diagnosis of moderate-to-severe HS. The primary endpoint in both trials was HiSCR50 at Week 16. A key secondary endpoint was HiSCR75 at Week 16. 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.
About BIMZELX (bimekizumab-bkzx)
Bimekizumab 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.
In the U.S., BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. BIMZELX is not approved in the U.S. for the treatment of moderate-to-severe hidradenitis suppurativa (HS), PsA, nr-axSpA and AS, or for the 2mL device presentation. In the U.S., the efficacy and safety of BIMZELX in the treatment of moderate-to-severe HS, PsA, nr-axSpA, and AS have not been established, and these are investigational indications.
BIMZELX is not approved in HS by any regulatory authority worldwide.
Please see Important Safety Information below and full U.S. prescribing information at www.UCB-USA.com/Innovation/Products/BIMZELX.
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).
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