Bimekizumab Under FDA Review for Hidradenitis Suppurativa

On April 4, 2024, the US Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) to review bimekizumab-bkzx, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).

The agency also accepted a second sBLA for a bimekizumab-bkzx 2-mL device.

The developments were announced in a press release from UCB, the manufacturer of bimekizumab-bkzx (Bimzelx), which was first approved in the United States in October 2023 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

According to the press release, acceptance of the sBLA was based on results from two phase 3 studies known as BE HEARD I and BE HEARD II, which found that bimekizumab-bkzx showed clinically meaningful improvements compared with placebo at week 16 and were sustained to week 48. If approved, this would be the first HS approval for bimekizumab-bkzx worldwide. In the European Union, it is approved for treating adults with psoriatic arthritis and axial spondyloarthritis, in addition to moderate to severe psoriasis.

According to the company, approval of the 2-mL injection device would mean that patients would have an alternative one-injection regimen option; currently, one dose for psoriasis is administered as two 1-mL injections. Full US prescribing information for bimekizumab-bkzx can be found here.

A version of this article first appeared on Medscape.com.