Press release

September 23, 2020
1 min read

FDA, EMA accept bimekizumab applications for plaque psoriasis


Press release

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A biologics license application for bimekizumab has been accepted by the FDA for the treatment of adults with moderate to severe plaque psoriasis, according to a press release.

In addition, the European Medicines Agency has accepted a marketing authorization application for the same indication.

Phase 3 clinical trials of bimekizumab (UCB) showed superior skin clearance and rapid response at week 16 compared with patients treated with Humira (adalimumab, AbbVie), Stelara (ustekinumab, Janssen) and placebo.

“This milestone brings us one step closer to being able to offer a meaningful new treatment option for people living with this debilitating disease. UCB is committed to providing innovative solutions for people living with serious inflammatory diseases like psoriasis,” Emmanuel Caeymaex, executive vice president immunology solutions and head of U.S., UCB, said in the release.

Bimekizumab is also being evaluated for the treatment of psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondylarthritis and hidradenitis suppurativa, the release said.