FDA postpones review of bimekizumab biologics license application

Key takeaways:

• The FDA review of bimekizumab’s biologics license application was expected in the second quarter of 2023.
• UCB now anticipates the FDA will review the application in the third quarter.

The FDA review of the biologics license application for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis has been postponed to the third quarter of 2023, UCB announced in a press release.

Based on communication with the FDA, UCB previously announced that it expected a decision on the drug’s biologics license application in the second quarter of this year.

According to the press release, the company “is committed to ongoing collaboration with the FDA in order to bring bimekizumab to people in the U.S. living with moderate to severe plaque psoriasis as soon as possible.”

Bimekizumab, an interleukin (IL)-17F and IL-17A inhibitor, is approved for moderate to severe psoriasis in 39 countries and by 10 regulatory authorities. The drug was also recently approved for two additional indications in the European Union.

After issuing a complete response letter in May 2022, the FDA accepted the company’s resubmission for bimekizumab in December 2022. If approved, bimekizumab will be the first dual IL-17A and IL-17F inhibitor for the treatment of patients with moderate to severe plaque psoriasis in the U.S.