FDA Approves UCB's Psoriasis Drug For Expanded Use In Painful Inflammatory Skin Disease

On Wednesday, the FDA approved UCB SA’s UCBJY UCBJF Bimzelx (bimekizumab-bkzx) for adults with moderate to severe hidradenitis suppurativa (HS).

Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A).

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Hidradenitis suppurativa is a chronic inflammatory skin disease.

The main symptoms are nodules, abscesses, and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin, and buttocks.

Data from two Phase 3 studies, BE HEARD I and BE HEARD II, support the approval.

Results showed that a higher proportion of patients treated with bimekizumab-bkzx vs. placebo achieved a 50% or greater improvement in signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials.

Bimekizumab-bkzx treatment also resulted in clinically meaningful improvements in the key ranked secondary endpoint, HiSCR75, vs. placebo at Week 16. Clinical responses were sustained to Week 48.

This FDA approval of bimekizumab-bkzx for adults with moderate to severe hidradenitis suppurativa follows its recent approvals for the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis.

Bimekizumab-bkzx was first approved in the U.S. in October 2023 for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

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