IL-17A/F inhibitor wins FDA approval for the treatment of plaque psoriasis

The FDA has approved bimekizumab (Bimzelx), a humanized interleukin-17A and F antagonist, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Approval was based on data from three phase 3 trials that evaluated bimekizumab vs. placebo and ustekinumab (BE VIVID); vs. placebo (BE READY); and vs. adalimumab (BE SURE). The most common ADRs reported were URTI, oral candidiasis, headache, injection site reactions, tinea and candida infections, gastroenteritis, HSV infections, acne, folliculitis, and fatigue.