EU regulatory filing for bimekizumab for the treatment of moderate to severe hidradenitis suppurativa

The application for HS is supported by data from the Phase III BE HEARD I and BE HEARD II studies which were previously communicated. 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.

Notes to editors: *p=0.006 and p=0.003 for BE HEARD I and BE HEARD II, respectively with bimekizumab every two weeks (Q2W); p=0.030 and p=0.004 for BE HEARD I and BE HEARD II, respectively with bimekizumab every four weeks (Q4W).