FDA, EMA accepts marketing applications for bimekizumab in psoriasis

UCB has announced both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA) for bimekizumab (UCB) for the treatment of moderate-to-severe plaque psoriasis in adults. While these acceptances position the biologic to be marketed, bimekizumab has yet to be approved by any regulatory agency.

Bimekizumab is an investigational humanized monoclonal IgG1 antibody designed to inhibit interleukin (IL)-17A and IL-17F, both of which are thought to be key cytokines in the inflammatory process.

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The decisions are backed by positive data from multiple phase 3 studies (BE READY, BE SURE, BE VIVID) investigating the safety and efficacy of bimekizumab in adult moderate-to-severe chronic plaque psoriasis patients. All primary endpoints were met across all phase 3 studies, with bimekizumab-treated patients demonstrating superior skin clearance at week 16 versus patients treated with adalimumab (Humira, AbbVie) and placebo as measured by the Psoriasis Severity Index (PASI 90) and Investigator Global Assessment (IGA) response of clear (0) or almost clear (1), according to the press release.

Additionally, all phase 3 studies met their secondary endpoints. In two of the studies, bimekizumab-treated patients showed total skin clearance at week 16 (PASI 100), verifying superiority over ustekinumab (Stelara, Janssen Pharmaceutical Companies of Johnson & Johnson) and adalimumab. Bimekizumab was superior to ustekinumab, adalimumab and placebo in achieving rapid response (PASI 75 at week 4) and clinical responses were sustained up to one year across all studies. Also, the studies’ safety profiles were consistent with previous clinical studies.

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"After a series of positive phase 3 data readouts, we are delighted to announce that the U.S. FDA and EMA have accepted our applications to file bimekizumab as a potential new treatment for psoriasis. This milestone brings us one step closer to being able to offer a meaningful new treatment option for people living with this debilitating disease. UCB is committed to providing innovative solutions for people living with serious inflammatory diseases like psoriasis," said Emmanuel Caeymaex, executive vice president of Immunology Solutions and head of UCB operations in the U.S.

Currently, bimekizumab is undergoing phase 3 trials investigating the biologic as a treatment for psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis and hidradenitis suppurativa.

References:

Ucb. (2020, September 22). UCB Achieves Important Regulatory Milestone for Bimekizumab. Retrieved September 22, 2020, from https://www.prnewswire.com/news-releases/ucb-achieves-important-regulatory-milestone-for-bimekizumab-301135154.htm