UCB’s Bimzelx (bimekizumab) has been approved by the European Commission (EC) to treat active moderate-to-severe hidradenitis suppurativa (HS) in adults who have had an inadequate response to conventional systemic therapy.
Estimated to affect about 1% of the population in most studied countries, HS is an inflammatory skin disease that causes nodules, abscesses and pus-discharging draining tunnels. Many patients experience flare-ups of the disease as well as severe pain.
Bimzelx is designed to selectively inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes, and is already approved in the EU to treat plaque psoriasis, psoriatic arthritis and axial spondyloarthritis.
The EC’s latest authorisation for the therapy follows a recent recommendation from the European Medicines Agency’s human medicines committee and is supported by positive data from the phase 3 BE HEARD I and BE HEARD II studies.
Results showed that Bimzelx was associated with statistically significant and clinically meaningful improvements over placebo in the signs and symptoms of adults with moderate-to-severe HS as measured by HiSCR50 at week 16, with responses maintained to week 48.
Treatment with Bimzelx also resulted in improvements over placebo in the high threshold endpoint, HiSCR75, at week 16, a key ranked secondary endpoint, with these responses also sustained to week 48.
Emmanuel Caeymaex, executive vice president, immunology solutions and head of US, UCB, said: “We are proud to bring the first and only approved medicine targeting IL-17A and IL-17F to the HS community. We believe that [Bimzelx] has the potential to transform care for people living with moderate-to-severe disease.”
Dr Christos Zouboulis of Brandenburg Medical School and president of the European Hidradenitis Suppurativa Foundation, described the authorisation as a “significant milestone for the EU HS community”.
He continued: “As a community, we strive to improve the management of HS. [Bimzelx] 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 approval comes just over a month after UCB announced the first presentation of four-year data for Bimzelx in moderate-to-severe plaque psoriasis.
Pooled data for the drug from treatment initiation to four years, presented at this year’s American Academy of Dermatology Annual Meeting, showed that high rates of clinical and health-related quality-of-life responses were rapidly achieved and maintained in the long term.