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FDA delays action on BLA for UCB’s Bimzelx® (bimekizumab)

Jun 26, 2023

UCB announced that its Biologics License Application (BLA) for bimekizumab to treat moderate to severe plaque psoriasis remains under review with the FDA.  The FDA acceptance was expected in Q2, 2023, however it is not anticipated that the FDA will do so in Q3 2023.  Bimekizumab is an IL-17A and IL-17F inhibitor, is currently approved for moderate to severe psoriasis by 10 regulatory authorities and in 39 countries worldwide.

In June 2023, bimekizumab was approved for two additional indications in Europe – the treatment of adults with active psoriatic arthritis, and for the treatment of adults with active axial spondyloarthritis (axSpA), including non-radiographic axSpA and ankylosing spondylitis, also known as radiographic axSpA.