FDA accepts BLA resubmission for bimekizumab

Following a previous rejection by the agency, the US Food and Drug Administration (FDA) has now accepted for review the Biologics License Application (BLA) resubmission for bimekizumab, filed by Belgium’s largest drugmaker UCB (Euronext Brussels: UCB), for the treatment of adults with moderate to severe plaque psoriasis.

The FDA designated the resubmission as ‘Class 2’ with a six-month review period. The FDA action is expected in the second quarter of 2023.

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