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Bimekizumab FDA Approval Status

Last updated by Judith Stewart, BPharm on May 16, 2022.

FDA Approved: No
Generic name: bimekizumab
Company: UCB, Inc.
Treatment for: Plaque Psoriasis

Bimekizumab is an investigational humanized IgG1 monoclonal antibody in development for the treatment of moderate to severe plaque psoriasis in adults.

  • Bimekizumab is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving the inflammatory process in plaque psoriasis.
  • Interim data from BE BRIGHT, an open-label extension (OLE) trial to assess the long-term safety, tolerability and efficacy of bimekizumab showed that the majority of patients who achieved complete or near complete skin clearance after 16 weeks of bimekizumab treatment maintained these responses through to two years with continuous maintenance dosing, every four weeks (Q4W) or every eight weeks (Q8W).
  • In the BE READY, BE VIVID and BE SURE Phase 3 studies, the most frequently reported treatment-emergent adverse events in bimekizumab-treated patients were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.
  • On May 13, 2022, UCB announced that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. The letter indicated that certain pre-approval inspection observations must be resolved before the application can be approved.

Development timeline for bimekizumab

May 13, 2022Update on U.S. FDA Review of Biologics License Application (BLA) for Bimekizumab - Complete Response Letter
Oct 22, 2021UCB Presents Number Needed to Treat Analysis for Bimekizumab in Moderate to Severe Plaque Psoriasis at AMCP Nexus
Oct 16, 2021Update on U.S. FDA Review of Biologics License Application (BLA) for Bimekizumab
Sep 29, 2021New Bimekizumab Two-Year Data in Moderate to Severe Plaque Psoriasis Presented at the 30th European Academy of Dermatology and Venereology Congress
Aug  7, 2021New Two-Year Data Showed Bimekizumab Maintained High Levels of Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis
Apr 28, 2021UCB Announces PDUFA Date for Bimekizumab
Apr 23, 2021The New England Journal of Medicine Publishes Results from Two Bimekizumab Phase 3 Studies in Moderate to Severe Plaque Psoriasis
Mar  2, 2019Bimekizumab Demonstrated Long-Term Maintenance of Complete or Almost Complete Skin Disease Resolution for Psoriasis Patients in BE ABLE 2 Extension Study

Further information

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