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U.S. FDA Approves UCB’s Bimekizumab (Bimzelx) for Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis

The U.S. Food and Drug Administration (FDA) has approved bimekizumab-bkzx (Bimzelx, UCB) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS).

Bimekizumab is the first approved treatment for these three indications that is designed to selectively inhibit interleukin 17A (IL-17A) and IL-17F. These newly approved indications follow the first U.S. approval for bimekizumab in October 2023 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

The FDA recommended dosage of bimekizumab for adult patients with active PsA, active nr-axSpA with objective signs of inflammation, and active AS is 160mg by subcutaneous injection every four weeks. For PsA patients with coexistent moderate-to-severe plaque psoriasis, the dosage and administration is the same as for patients with moderate-to-severe plaque psoriasis.