The European Commission has granted marketing authorization for UCB’s Bimzelx (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.¹ Bimzelx is the first IL-17A and IL-17F biologic for the treatment of 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,” 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, said in a company 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.” 

The European Commission 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. In those studies, a significantly higher proportion of patients treated with bimekizumab versus placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials. Bimekizumab treatment also resulted in clinically meaningful improvements in the ranked key secondary endpoint, HiSCR75 versus placebo at Week 16. Responses were maintained to Week 48. The safety profile of bimekizumab was consistent with safety data seen in previous trials with no new observed safety signals.

“We are proud to bring the first and only approved medicine targeting IL-17A and IL-17F to the HS community. We believe that bimekizumab has the potential to transform care for people living with moderate to severe disease,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US. “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.”

In addition to HS, bimekizumab is approved in Europe for the treatment of plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis.