Posted by Michael Wonder on 01 Jun 2020
Lilly's Taltz (ixekizumab) is the first IL-17A antagonist to receive U.S. FDA approval for the treatment of non-radiographic axial spondyloarthritis
1 June 2020 - Taltz is now approved to treat patients across the full axSpA spectrum, including ankylosing spondylitis, also known as radiographic axSpA, and nr-axSpA.
Eli Lilly announced today the U.S. FDA has approved a supplemental biologics license application for Taltz (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. Another first-in-class milestone for the treatment, today's approval makes Taltz the first IL-17A antagonist to be approved by the FDA for nr-axSpA.
This approval is based on the results from the Phase 3 COAST-X trial, which evaluated improvement in signs and symptoms of nr-axSpA as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response criteria compared to placebo. ASAS40 measures disease signs and symptoms such as pain, inflammation and function.
