UCB Achieves Important Regulatory Milestone for Bimekizumab
(WorldNews Belgium)

· The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted marketing application submissions for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis · This accepted submission is supported by a robust data package including three Phase 3 studies which demonstrate superiority of bimekizumab to placebo, Stelara[®] (ustekinumab) and Humira[®] (adalimumab) in achieving skin clearance at week 16 Brussels, Belgium - 22th September 2020, 07:00 CEST - UCB, a global biopharmaceutical company, today announced that the FDA and EMA have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA),...