Bimzelx approved by EC as the first IL-17A and IL-17F biologic for moderate to severe HS

The European Commission (EC) has granted marketing authorization for the interleukin (IL)-17A and IL-17F inhibitor Bimzelx (bimekizumab), from Belgian drugmaker UCB's (Euronext: UCB), for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.

The approval follows a positive opinion issued in March 2024 by the European Medicines Agency advisory committee, the CHMP. The EC approval was granted based on results from two Phase III studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bimekizumab in the treatment of moderate to severe HS.

In Europe, Bimzelx is already approved for the treatment of plaque psoriasis, non- radiographic axial spondyloarthritis and psoriatic arthritis, while in the USA it is authorized for plaque psoriasis.