UCB, a leading global biopharmaceutical company, has announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a favorable opinion, recommending the granting of marketing authorization for BIMZELX® (bimekizumab) within the European Union (EU)/European Economic Area (EEA). This recommendation pertains to the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults who have had an inadequate response to conventional systemic HS therapy. Pending approval by the European Commission (EC), bimekizumab stands to become the first IL-17A and IL-17F inhibitor approved in the EU for addressing moderate to severe HS in adults.
Emmanuel Caeymaex, Executive Vice President, Immunology Solutions, and Head of U.S., UCB, expressed the significance of this positive opinion, stating, “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.” If approved, this would mark the fourth marketing authorization for bimekizumab in three years, complementing its existing indications in moderate to severe plaque psoriasis, active psoriatic arthritis, and active axial spondyloarthritis.
Hidradenitis suppurativa (HS) is characterized by chronic inflammation, presenting as nodules, abscesses, and fistulas in areas such as the armpits, groin, and buttocks. It affects about one percent of the population in most studied countries, causing flare-ups and severe pain. Individuals with HS also endure social stigma, isolation, and low self-esteem, significantly impacting their quality of life.
The CHMP’s positive opinion for bimekizumab is rooted in data from the Phase 3 BE HEARD I and BE HEARD II studies, assessing its efficacy and safety in adults with moderate to severe HS. Results indicated that bimekizumab led to statistically significant and clinically meaningful improvements over placebo in HS signs and symptoms, as measured by HiSCR50 at Week 16, the primary endpoint, with sustained responses up to Week 48. Additionally, bimekizumab demonstrated improvements over placebo in the high threshold endpoint, HiSCR75 at Week 16, a crucial secondary endpoint, with sustained responses up to Week 48. The safety profile of bimekizumab remained consistent with previous studies, with no new safety concerns identified.
The CHMP’s positive opinion on bimekizumab in moderate to severe HS will now undergo review by the EC for its final decision. If approved, the marketing authorization will apply to all EU member states and countries within the EEA.
