UCB S.A.'s hopes of launching Bimzelx in the US this year have been scuppered again by regulators across the Atlantic who have rejected the potential blockbuster for inflammatory diseases, citing facility inspection issues.
Bimzelx (bimekizumab) comfortably secured approval for psoriasis in the EU and the UK in August last year but the regulatory road has been rocky in the US. In October 2021, the Food and Drug Administration said it was unable to complete a review of the biologics license application for the IL-17A and IL-17F inhibitor until on-site inspections of the European manufacturing facilities for the drug were carried out