Trio of indications for Bimzelx among FDA’s September label expansions 

FDA added new indications to the labels of at least nine products in September, and converted two accelerated approvals to full.

UCB S.A. (Euronext:UCB) received label expansions for two antibody therapies. Its IL-17A/F mAb Bimzelx bimekizumab, which was approved in 2023 for plaque psoriasis, added three new indications — psoriatic arthritis, active ankylosing spondylitis and active non-radiographic axial spondyloarthritis. The product, which had €85 million ($91 million) in U.S. sales during the first half of this year, is also under FDA review for moderate-to-severe hidradenitis suppurativa. UCB’s TNFɑ antibody Cimzia certolizumab pegol received approval for active polyarticular juvenile idiopathic arthritis in children 2 years of age and older. ...