FDA approve Cimzia (UCB) for Ankylosing Spondylitis

The FDA has approved Cimzia (certolizumab pegol), from UCB, for the treatment of adults with active Ankylosing Spondylitis (AS). The FDA also issued a Complete Response Letter relating to the supplemental Biologics License Application of Cimzia for the treatment of adults with active Axial Spondyloarthritis (axSpA). UCB is working with the FDA to determine a path forward to bring Cimzia to US patients living with active axSpA.

Approval of Cimzia for adults with active AS was based on a Phase III study designed to evaluate the efficacy and safety of Cimzia in patients with active axSpA, in which the majority had AS. In the efficacy and safety study, the proportion of patients achieving an ASAS20 response rate at week 12 was met with clinical and statistical significance in both dosing arms versus placebo. Adverse events occurred in 70.4% of patients in the Cimzia group (combined dose) compared to 62.6% of patients on placebo. Serious adverse events occurred in 4.7% of patients in both groups.