Bimekizumab Fails FDA Pre-Approval Inspection

UCB announced the FDA issued a CRL that stated that the FDA cannot approve the BLA in its current form.

The FDA issued a Complete Response Letter (CRL) to UCB regarding its Biologics License Application (BLA) for bimekizumab (Bimzelx, UCB), a potential treatment of adults with moderate to severe plaque psoriasis.

In the letter, the FDA states it cannot approve the BLA in its current form. Certain pre-approval inspection observations made during the approval process need resolved before going forward, according to the press release. “We are cooperating with the FDA and are working to address these observations as expeditiously as possible,” UCB stated.

This comes after the FDA’s approval of the biologic was delayed in 2021. The interleukin (IL)-17 inhibitor for plaque psoriasis and psoriatic arthritis blocks IL-17 A and IL-17 F cytokines.

Reference:

Update on US FDA review of biologics license application (BLA) for bimekizumab | UCB. Accessed May 16, 2022. https://www.ucb.com/stories-media/Press-Releases/article/Update-on-US-FDA-Review-of-Biologics-License-Application-BLA-for-bimekizumab-0