The European Commission (EC) has granted marketing authorization for bimekizumab (Bimzelx, UCB) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic therapy.
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 3 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 U.S. Food and Drug Administration (FDA) recently accepted UCB’s supplemental Biologics License Application (sBLA) for bimekizumab-bkzx (Bimzelx, UCB), an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with 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,” says 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, in a news release. “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.”
“Hidradenitis suppurativa can have a devastating impact on people, especially those with moderate to severe disease. In addition to the physical symptoms, there can also be a considerable psychological burden for many people, resulting in a reduced quality of life and missing out on important life events,” says Barry McGrath, PhD, Co-Founder of HS Ireland, an association for all people affected by hidradenitis suppurativa in Ireland. “The possibility of a new treatment option to help people living with this disease is most welcome.”
“We are proud to bring the first and only approved medicine targeting IL-17A and IL-17F to the hidradenitis suppurativa community. We believe that bimekizumab has the potential to transform care for people living with moderate to severe disease,” adds Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S. “Today’s approval signifies the expansion of bimekizumab to its fourth approved indication within the European Union. This milestone achievement underscores our unwavering commitment to raising standards of care across a spectrum of IL-17 mediated diseases.”
