The US FDA has approved a supplemental Biologics License Application (sBLA) for Taltz (ixekizumab). The drug is indicated for ankylosing spondylitis (AS), also known as radiographic axSpA, and nr-axSpA. Taltz is the first IL-17A antagonist indicated for nr-axSpA.
The approval is based on Phase 3 COAST-X trial, a multicenter, randomized, double-blind, placebo-controlled 52-week study in adult patients. The trial demonstrated the improvement signs and symptoms of nr-axSpA measured by the Assessment of Spondyloarthritis International Society 40 (ASAS40) at week 52. 30% of patients treated with Taltz 80 mg every four weeks achieved ASAS40 compared to 13% in the placebo arm. The safety profile is consistent with other indications.
"In the COAST-X study, Taltz provided relief to nr-axSpA patients living with debilitating symptoms such as chronic back pain and fatigue," said Atul Deodhar, M.D., Oregon Health & Science University.
Taltz is an interleukin 17A receptor antagonist. It was previously approved for psoriatic arthritis, ankylosing spondylitis, plaque psoriasis in adults, and pediatrics. It further inhibits cytokines and chemokines.
Axial spondyloarthritis (axSpA)
Axial spondyloarthritis includes ankylosing spondylitis and non-radiographic axial spondyloarthritis. Limited treatment options are available for non-radiographic axial spondyloarthritis. Both the two patient subsets have similar disease burden.