UCB nears fourth EU nod for Bimzelx, this time in hidradenitis suppurativa

2024-03-22

临床3期上市批准临床结果

A drug review committee for the European Medicines Agency (EMA) recommended approval of UCB’s Bimzelx (bimekizumab) for hidradenitis suppurativa (HS) on Friday, moving the antibody one step closer to clinching its fourth approval in the EU.

The dual IL-17A and IL-17F inhibitor IL-17F inhibitor is already approved by the EMA to treat plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. Last year, Bimzelx scored a long-awaited FDA approval for psoriasis (see – KOL Views Q&A: Early look at how UCB’s Bimzelx is faring in battle with IL-17s and IL-23s in psoriasis).

The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Bimzelx based on two Phase III trials, BE HEARD I and BE HEARD II.

The studies enrolled 1014 patients with moderate-to-severe HS to receive a Bimzelx injection either every two weeks, every four weeks, or placebo.

At week 16, Bimzelx led to statistically significant and clinically meaningful improvements over placebo as measured by Hidradenitis Suppurativa Clinical Response (HiSCR50), meeting the primary endpoint.

If approved, Bimzelx would become the third therapy available for HS patients in the EU, following AbbVie’s Humira (adalimumab) and Novartis’ Cosentyx (secukinumab). More options could be on the horizon, however, as the next generation of HS treatments, which are directed against several new targets, reach late-stage testing. For more, see KOL Views Q&A: Leading dermatologist optimistic about next wave of HS treatments.