Cimzia Gains New Ankylosing Spondylitis Indication
The approval of Cimzia for adults with active ankylosing spondylitis was based on a Phase 3, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Cimzia in patients with active axial spondyloarthritis, in which the majority had ankylosing spondylitis. The primary efficacy endpoint, the proportion of patients achieving an ASAS20 response rate at Week 12, was met with clinical and statistical significance in both Cimzia dosing arms (200mg every 2 weeks or 400mg every 4 weeks) vs. placebo.
Cimzia is currently approved for the treatment of adults with active psoriatic arthritis, moderately-to-severely active rheumatoid arthritis, and for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately-to-severely active disease who have had an inadequate response to conventional therapy.
The FDA has also issued a Complete Response Letter relating to the supplemental Biologics License Application (sBLA) of Cimzia for the treatment of adults with active axial spondyloarthritis.For more information call (800) 477-7877 or visit Cimzia.com.