Bimekizumab receives FDA approval for the treatment of moderate-to-severe plaque psoriasis

On October 18, 2023, the U.S. Food and Drug Administration (FDA) approved bimekizumab, an interleukin (IL)-17 inhibitor, for use in patients with moderate-to-severe plaque psoriasis. This approval follows results from the phase III BE READY, BE VIVID, and BE SURE trials. All studies met their primary and ranked secondary endpoints. At Week 16, between 85% and 91% of patients achieved clear or almost clear skin, and complete clearance was observed in 59–68% of patients. Outcomes from BE READY, BE VIVID, and BE SURE have been previously reported on the Psoriasis and Psoriatic Arthritis Hub.

Bimekizumab is the first approved treatment for psoriasis that inhibits both IL-17A and IL-17F. The FDA recommended subcutaneous dose of bimekizumab is 320 mg (two doses of 160 mg) at Weeks 0, 4, 8, 12, 16, and then every 8 weeks. Once the patient has received training, they are able to self-administer bimekizumab.