The FDA delayed its approval decision for UCB’s psoriasis drug bimekizumab Biologics License Application (BLA) for the second time, this time issuing a complete response letter.
Last year, COVID limitations caused the agency to push back the timeline on their approval decision as international on-site inspections became backed up. Specifically, the FDA wanted to conduct on-site inspections of the European manufacturing facilities for bimekizumab before approving UCB's application.
However, this week UCB was told in an FDA complete response letter that the BLA cannot be approved in its current form and that certain pre-approval inspections must be resolved first. The Belgian biotech says it is working with the FDA to meet their observations as “expeditiously as possible.”
Bimekizumab works by inhibiting and therefore regulating cytokine action, also known as cell signaling proteins known to be immunomodulating agents. The drug has received marketing authorization from various international agencies for the treatment of psoriasis, enabling the drug to compete head to head against J&J’s blockbuster star Stelara around the world.