Bimekizumab receives FDA approval for the treatment of psoriatic arthritis

On September 23, 2024, the U.S Food and Drug Administration (FDA) approved bimekizumab, an interleukin (IL)-17 inhibitor that dually inhibits IL-17A and IL-17F, for the treatment of active psoriatic arthritis (PsA) in adults, in addition to active non-radiographic axial spondylarthritis and active ankylosing spondylarthritis.¹ Bimekizumab was previously approved for the treatment of moderate-to-severe plaque psoriasis.¹  

The approval in PsA follows positive results from the phase III multicenter, randomized, placebo-controlled BE OPTIMAL and BE COMPLETE trials, which met the primary endpoint of 50% improvement in American College of Rheumatology response (ACR50) at Week 16.¹ Responses were sustained to Week 52 in these trials and the open-label extension.¹ 

This expanded indication makes bimekizumab a promising treatment option in patients with psoriasis at risk of PsA or in those with concurrent PsA.