Posted by Michael Wonder on 26 Aug 2019
Lilly receives U.S. FDA approval for Taltz (ixekizumab) for the treatment of active ankylosing spondylitis (radiographic axial spondyloarthritis)
26 August 2019 - Eli Lilly and Company announced today that the U.S. FDA has approved Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).
This is the third indication for Taltz, which was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and then approved by the FDA in December 2017 for the treatment of adults with active psoriatic arthritis.
The efficacy and safety of Taltz in AS was demonstrated in two randomized, double-blind, placebo-controlled Phase 3 studies that included 657 adult patients with active AS: COAST-V in patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve and COAST-W in patients who previously had an inadequate response or were intolerant to tumour necrosis factor inhibitors.
