UCB’s Bimzelx earns fifth FDA approval for hidradenitis suppurativa

UCB has achieved a significant milestone with the U.S. FDA granting approval for a fifth indication of its drug Bimzelx (bimekizumab). This latest approval allows Bimzelx to be used for treating active moderate-to-severe hidradenitis suppurativa (HS) in adults who have not responded adequately to conventional systemic therapies. This follows a similar approval by the European Union in April.

Bimzelx had initially received FDA approval for treating plaque psoriasis last year, despite some delays. This was followed by three more approvals for treating active psoriatic arthritis, non-radiographic axial spondyloarthritis, and active ankylosing spondylitis in adults. These approvals underscore UCB's dedication to addressing unmet medical needs in immunological conditions, as emphasized by Emmanuel Caeymaex, UCB's chief commercial officer.

The recent approval for treating HS is supported by data from the Phase III BE HEARD I and BE HEARD II trials. In these trials, Bimzelx demonstrated significant and clinically meaningful improvements on the Hidradenitis Suppurativa Clinical Response (HiSCR50) compared to a placebo at the 16-week mark. These positive effects were sustained up to week 48.

A key opinion leader (KOL) interviewed by FirstWord after Bimzelx's EU approval suggested that IL-17 inhibitors, such as Bimzelx, are expected to emerge as the standard first-line therapy for HS patients with fistulas. For those without fistulas, it could become a second-line option following adalimumab. The KOL also noted that Bimzelx is likely to be preferred over Novartis’ Cosentyx (secukinumab) due to its better efficacy, although Bimzelx has a higher rate of fungal infections.

Analysts at Jefferies believe that Bimzelx could secure a 45% market share in the HS treatment space by 2032, assuming that Moonlake Immunotherapeutics' nanobody sonelokimab does not outperform it in terms of efficacy. Moonlake's candidate showed promising results by achieving the primary endpoint in a mid-stage HS study last year.