European Commission approves Bimzelx (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa

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

“The European Commission’s approval of bimekizumab marks a significant milestone for the EU hidradenitis suppurativa community, particularly considering the limited treatment options currently available,” said Prof. Dr. Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation (EHSF) e.V. and Director of the Departments of Dermatology, Venereology, Allergology and Immunology, Städtisches Klinikum Dessau, Brandenburg Medical School, Germany. “As a community, we strive to improve the management of hidradenitis suppurativa. Bimekizumab offers a promising new therapeutic option for moderate to severe disease, supported by Phase 3 evidence that demonstrated clinically meaningful and sustained responses over 48 weeks.”