Bimzelx (bimekizumab), a monoclonal antibody that inhibits two cytokines driving inflammation, has been approved in the US for the treatment of moderate to severe plaque psoriasis. The Food and Drug Administration cleared the drug for use on 18 October, more than a year after issuing a complete response letter to the developer, UCB SA of Belgium. The CRL was related to certain “pre-approval inspection observations,” according to the company.
