Posted by Michael Wonder on 22 Mar 2024
UCB receives positive CHMP opinion for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe hidradenitis suppurativa
22 March 2024 - Positive CHMP opinion is supported by data from the two Phase 3 studies, BE HEARD I and BE HEARD II, where bimekizumab showed clinically meaningful improvements versus placebo at Week 16 which were sustained to Week 48.
UCB today announced that the CHMP of the EMA has issued a positive opinion recommending granting marketing authorisation for Bimzelx (bimekizumab) in the European Union/European Economic Area for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy.
