FDA Delays Bimekizumab Decision, Again Save

Editor's Note: please note the error in the original report has been corrected to read: UCB affirms there are no open information requests from the FDA regarding the BLA for bimekizumab or bimekizumab manufacturing.

UCB, the maker of the IL-17 A/F inhibitor bimekizumab (BMK), has announced that the FDA decision on BMK use in adults with moderate to severe plaque psoriasis has been delayed until the 3rd quarter of 2023.

The FDA's decision on BMK was expected June 2023.  No reason for the delay was provided by either the FDA or UCB. UCB affirms there are no open information requests from the FDA regarding the BLA for bimekizumab or bimekizumab manufacturing.

Bimekizumab is a monoclonal antibody that inhibits interleukin (IL)-17A and IL-17F, two drivers of inflammation. The manufacturer, UCB, is seeking approval in the United States for the treatment of adults with moderate to severe plaque psoriasis.

Bimekizumab has already been approved for moderate to severe psoriasis in the European Union as well as in Canada, Australia, Japan, and Saudi Arabia. Earlier in June 2023, the European Commission approved the drug for use in active psoriatic arthritis and axial spondyloarthritis, and will be marketed as Bimzelx. 

This delay follows an October 2021 FDA delay in the BLA for bimekizumab because COVID-19 travel restrictions that delayed inspection of manufacturing facilities in Europe.