UCB Receives Positive CHMP Opinion for Bimekizumab for Moderate to Severe HS

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UCB recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for bimekizumab (Bimzelx) in the European Union (EU) for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. If approved, bimekizumab will be the first IL-17A and IL-17F inhibitor approved in Europe for adults with moderate to severe HS.

The positive CHMP opinion is based on data from the phase 3 BE HEARD I (NCT04242446) and BE HEARD II (NCT04242498) clinical trials that evaluated the safety and efficacy of bimekizumab for the treatment of moderate to severe HS. The phase 3 data demonstrated that bimekizumab treatment resulted in statistically significant and clinically meaningful improvements over placebo in the signs and symptoms of HS measured by HiSCR50 at week 16, the primary endpoint of the studies, with responses sustained to week 48.

The phase 3 data also showed improvements over placebo in the high threshold end point of a HiSCR75 score at week 16, a key ranked secondary end point, with responses sustained to week 48. The safety profile of bimekizumab was consistent in both studies and no new safety signals were reported.

Dermatology Times recently spoke with Christopher Sayed, MD, a dermatologist at the University of North Carolina Chapel Hill’s HS clinic who also served as an investigator for the BE HEARD trials.

“HS is a disease with lots of ups and downs. Having stable improvement tells you that the drug [bimekizumab] is really working. They didn't just happen to get better on the day they were measured at the week 16 time point. They're clearly moving in the right direction very steadily over time for patients,” Sayed concluded. “Part of the trouble that comes along with HS is the unpredictability, the fact that it can flare up anytime at all like you have a vacation plan when you have some big family event planned. So, the idea that you can be stable over a long period of time and have fewer ups and downs means sort of less dread hanging over that patient all the time,” said Sayed.

BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled, parallel group, multicenter, phase 3 studies evaluating the safety and efficacy of bimekizumab in adults with moderate to severe HS. The two studies had a combined enrolment of 1014 patients with a diagnosis of moderate to severe HS.

“The positive opinion from the CHMP represents a significant milestone toward bringing bimekizumab to people living with moderate to severe hidradenitis suppurativa, a chronic, painful inflammatory skin disease with limited treatment options,” said Emmanuel Caeymaex, the executive vice president of immunology solutions and the head of US relations of UCB, in the news release. “If approved by the European Commission, this would represent the fourth marketing authorization for bimekizumab in three years, adding to the existing indications in moderate to severe plaque psoriasis, active psoriatic arthritis, and active axial spondyloarthritis.”

Reference

UCB receives positive CHMP opinion for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa. News release. UCB. March 22, 2024. Accessed March 22, 2024. https://www.ucb.com/stories-media/Press-Releases/article/UCB-receives-positive-CHMP-opinion-for-BIMZELXRVbimekizumab-for-the-treatment-of-adults-with-moderate-to-severe-hidradenitis-suppurativa