FDA Approves Bimzelx for Expanded Indications: Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis

Expanded Indications:
The FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS).

Clinical Benefit:
The approval highlights the clinical benefit of dual inhibition of both IL-17A and IL-17F for patients, providing an opportunity for more people living with chronic inflammatory diseases to achieve meaningful outcomes.

Clinical Studies:
The approvals are supported by data from Phase 3 studies, including BE OPTIMAL and BE COMPLETE for PsA, and BE MOBILE 1 and BE MOBILE 2 for nr-axSpA and AS, respectively. These studies demonstrated statistically significant improvements in signs and symptoms at Week 16, which were sustained to Week 52.

Dosage:
The recommended dosage of Bimzelx for all three new indications is 160 mg by subcutaneous injection every four weeks. For PsA patients with co-existent moderate to severe plaque psoriasis, the dosage and administration is the same as for patients with moderate to severe plaque psoriasis.

First and Only: Bimzelx is the first and only IL-17A and IL-17F inhibitor approved in the U.S. for the treatment of four chronic immune-mediated inflammatory diseases:
PsA, nr-axSpA, AS, and moderate to severe plaque psoriasis.