FDA accepts resubmitted biologics license application for bimekizumab for plaque psoriasis

The FDA has accepted the biologics license application resubmission for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis, according to a UCB release.

In May, the FDA issued a complete response letter to the company stating its biologics license application (BLA) could not be approved until pre-approval observations were resolved. UCB resubmitted its BLA for bimekizumab in late November.

According to the release, the FDA has designated the resubmission as class 2 with a 6-month review period.

“The FDA acceptance of our resubmitted application for bimekizumab is positive news that moves us one step closer to providing the first dual [interleukin (IL)]-17A and IL-17F inhibitor to address the unmet needs of people with moderate to severe plaque psoriasis in the U.S.,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S., UCB, said in the release.

“We will continue to work with the FDA through the review process with the goal of bringing bimekizumab to the dermatology community in the U.S. as soon as possible,” Caeymaex continued.

UCB expects a response from the FDA in the second quarter of 2023, according to the release.