FDA accepts supplemental biologics license applications for Bimzelx (bimekizumab-bkzx) for moderate to severe hidradenitis suppurativa and additional 2 mL device presentations

UCB

4 April 2024 - Application in moderate to severe hidradenitis suppurativa based on results from two Phase 3 studies where bimekizumab-bkzx showed clinically meaningful improvements vs. placebo at Week 16 which were sustained to Week 48.

UCB today announced that the US FDA has accepted for review the supplemental biologics license application for Bimzelx (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa.

Read UCB press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier