EMA to Review UCB’s Bimekizumab for HS

The regulatory filing supported by data from two bimekizumab Phase 3 studies in hidradenitis suppurativa.

The European Medicines Agency (EMA) will reviww UCB’s marketing authorization application for bimekizumab for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).

Bimekizumab is an IL-17A and IL-17F inhibitor. The safety and efficacy of bimekizumab in HS have not been established, and it is not approved for use in HS by any regulatory authority worldwide.    

“This EU regulatory submission for bimekizumab reflects our pursuit to address unmet patient needs and to advance standards of care in hidradenitis suppurativa, especially given that few treatment options are available today. If approved, this would represent the fourth indication for bimekizumab in the European Union across a range of IL-17 mediated diseases,” says Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB, in a news release.

The application for HS is supported by data from the Phase 3 BE HEARD I and BE HEARD II studies. In both studies, bimekizumab demonstrated statistically significant and clinically meaningful improvements over placebo in signs and symptoms of HS at week 16, as measured by HiSCR50, the primary endpoint in the two studies, with maintained response to Week 48.Patients treated with bimekizumab also achieved deep levels of clinical response with a greater proportion achieving HiSCR75, a key secondary endpoint, at week 16 than placebo. The safety profile of bimekizumab across BE HEARD I and BE HEARD II was consistent with previous bimekizumab studies with no new safety signals observed.

In August 2021, bimekizumab first received marketing authorization in countries of the European Union (EU)/European Economic Area (EEA) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. In June 2023, bimekizumab was approved in countries of the EU/EEA for the treatment of adults with active psoriatic arthritis, and for the treatment of adults with active axial spondyloarthritis (axSpA), including non-radiographic axSpA and ankylosing spondylitis, also known as radiographic axSpA.