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UCB Awaits Two Regulatory Verdicts For Bimzelx

 
• By Elizabeth Cairns

An EU decision in hidradenitis suppurativa is important, but the long-delayed US decision in psoriasis – and the specifics of the label – is even more so.   

WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)
• Source: Sarah Silbiger/Getty Images (Sarah Silbiger/Getty Images)

The release of pooled, long-term data from the twin pivotal studies of UCB S.A.’s Bimzelx (bimekizumab) in the skin disease hidradenitis suppurativa (HS) sets the stage for the forthcoming EU regulatory decision. But a more consequential verdict for Bimzelx is also in the wings: the US Food and Drug Administration’s long-awaited decision on use of the antibody in psoriasis, and whether or not this will come with a black box warning.

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