UCB’s Bimzelx (bimekizumab) has been recommended by the European Medicines Agency’s human medicines committee to treat active moderate-to-severe hidradenitis suppurativa (HS).
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.
UCB’s bimekizumab is designed to selectively inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes. The drug is already approved in the EU to treat plaque psoriasis, psoriatic arthritis and axial spondyloarthritis.
The HS recommendation from the Committee for Medicinal Products for Human Use, which specifically applies to adults who have had an inadequate response to conventional systemic therapy, was 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, with these responses sustained to week 48.
Emmanuel Caeymaex, executive vice president, immunology solutions, and head of US at UCB, said: “The positive opinion from the CHMP represents a significant milestone toward bringing [Bimzelx] to people living with moderate-to-severe HS, a chronic, painful inflammatory skin disease with limited treatment options.”
The recommendation comes less than two weeks 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.
Caeymaex said at the time of the announcement: “These results, from the largest pool of phase 3 data, closely follow the US launch and reinforce our belief that Bimzelx has the potential to transform the lives of people with moderate-to-severe plaque psoriasis.”