Bimekizumab FDA Approval Status
Last updated by Judith Stewart, BPharm on May 16, 2022.
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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.