The U.S. Food and Drug Administration (FDA) approved the interleukin 17A and 17F inhibitor bimekizumab-bkzx (Bimzelx) to treat adult patients with moderate-to-severe plaque psoriasis. The FDA approval comes after researchers reported positive results with bimekizumab seen in three phase III trials. Compared with those who received ustekinumab, adalimumab, or placebo, patients treated with bimekizumab demonstrated superior levels of skin clearance after 16 weeks. The researchers found that about 70%, 80%, and 60% of those in the bimekizumab group achieved respective 75% improvements of their Psoriasis Area and Severity Index scores after 4 weeks and 90% and 100% improvements after 16 weeks. The FDA recommended that 320 mg of bimekizumab be administered in two subcutaneous injections at weeks 0, 4, 8, 12, and 16 of treatment and every 8 weeks thereafter. “The approval of bimekizumab will provide an important new treatment option for [patients] living with moderate-to-severe plaque psoriasis. Our hope is that new treatments translate into improved outcomes for many and help alleviate the physical and emotional burden of [the disease],” concluded Leah McCormick Howard, JD, President and Chief Executive Officer of the National Psoriasis Foundation.
November 01, 2023