UCB’s Bimzelx granted FDA approval to treat hidradenitis suppurativa in adults
UCB’s Bimzelx (bimekizumab-bkzx) has been approved by the US Food and Drug Administration (FDA) to treat active moderate-to-severe hidradenitis suppurativa (HS) in adults. Estimated to affect one in every 100 people in the US, HS is a chronic inflammatory skin disease that causes nodules, abscesses and pus-discharging fistulas, with many patients experiencing flare-ups as well as severe pain.
The FDA’s decision was supported by positive data from the late-stage BE HEARD I and BE HEARD II studies, in which a higher proportion of Bimzelx-treated patients achieved at least a 50% improvement in HS signs and symptoms, as measured by HiSCR50, at week 16 compared to placebo.
Treatment with Bimzelx also resulted in clinically meaningful improvements over placebo in the high threshold endpoint, HiSCR75, at week 16, a key ranked secondary endpoint, with clinical responses sustained to week 48.
Already approved in the US to treat certain patients with plaque psoriasis, psoriatic arthritis, axial spondyloarthritis and ankylosing spondylitis, Bimzelx is designed to selectively inhibit two key cytokines driving inflammatory processes, IL-17A and IL-17F.
BE HEARD I and II investigator and lead author, Alexa Kimball, Harvard Medical School, said: “The approval of Bimzelx in moderate-to-severe HS is welcome given the substantial unmet clinical needs and limited number of treatment options available today.” Sharing a similar sentiment, Brindley Brooks, founder and executive director of HS Connect, said: “The approval of Bimzelx is an exciting time for the HS community, offering a new possibility for the treatment of people in the US living with moderate-to-severe disease.”
The FDA’s decision follows the Medicines and Healthcare products Regulatory Agency’s June approval of Bimzelx in moderate-to-severe HS. The authorisation applies to patients who have had an inadequate response to conventional systemic HS therapy and was granted through the International Recognition Procedure, which takes into account prior authorisations from other regulatory partners.
The drug was also recently approved by the European Commission to treat HS after being recommended for this indication by the European Medicines Agency’s human medicines committee.
