FDA Decisions: UCB Nets Three More Indications for Inflammatory Disease Drug

Product: UCB’s Bimzelx

Indication: Psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis

UCB’s Bimzelx was approved Monday for not one, but three chronic immune-mediated inflammatory diseases: psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS). For all three indications, Bimzelx is the first approved medicine designed to selectively inhibit two key inflammation-driving cytokines, interleukin 17A (IL-17A) and interleukin 17F (IL-17F), according to UCB.

The approval of Bimzelx in active PsA is backed by two Phase III studies, in which the drug showed statistically significant improvements vs. placebo after 16 weeks in both joint and skin symptoms, results that were sustained to week 52. Meanwhile, across two Phase III studies in nr-axSpA and AS, Bimzelx demonstrated statistically significant improvements vs. placebo in signs and symptoms after 16 weeks—these results were also sustained up to one year.

Bimzelx was previously approved by the FDA in October 2023 for adult patients with plaque psoriasis who are candidates for systemic therapy or phototherapy.

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