Travel Restrictions Hinder Bimekizumab BLA Review

The Food and Drug Administration (FDA) is deferring action on the Biologics License Application (BLA) for bimekizumab for the treatment of moderate to severe plaque psoriasis due to COVID-19 related travel restrictions precluding an on-site facility inspection.

Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F. The BLA, which included data from three phase 3 studies, was submitted to the Agency in September 2020.

As part of the review process, the FDA had planned on inspecting the European manufacturing facilities for bimekizumab. Guidance established during the COVID-19 pandemic allows the Agency to defer action on an application if a facility inspection cannot be completed by the Prescription Drug User Fee Act (PDUFA) target date due to travel restrictions.

“We are currently in contact with the FDA to schedule the inspections of our manufacturing facilities as soon as possible,” said Prof Dr Iris Loew Friedrich, Chief Medical Officer and Executive Vice President, Development UCB. “We have provided the Agency with the manufacturing schedules through the first quarter of 2022, and we are eager to assist the FDA to allow its assessment of bimekizumab to be finalized.”

In clinical trials, bimekizumab was found to provide superior benefits over currently established plaque psoriasis treatments adalimumab, secukinumab, and ustekinumab.

Reference

Update on U.S. FDA Review of Biologics License Application (BLA) for bimekizumab. News release. October 16, 2021. https://www.prnewswire.com/news-releases/update-on-us-fda-review-of-biologics-license-application-bla-for-bimekizumab-301401710.html.