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.
Key Takeaways
- The CHMP will soon decide whether to recommend Bimzelx for hidradenitis suppurativa
Psoriasis is by far the most valuable of Bimzelx’s indications. It was approved for this use in Europe in August...
