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Cimzia Approved for Active Ankylosing Spondylitis

Receives Complete Response Letter for active axial spondyloarthritis indication

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By: Tim Wright

Editor-in-Chief, Contract Pharma

UCB received approval from the FDA for Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis (AS). The FDA also issued a Complete Response Letter relating to its sBLA for Cimzia in adults with active axial spondyloarthritis (axSpA). For this indication, UCB is working with the FDA to determine a path forward.
 
The approval was based on a Phase III, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Cimzia in patients with active axSpA, in which the majority had AS. The primary efficacy variable, 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. A greater proportion of AS patients treated with Cimzia 200 mg or 400 mg achieved ASAS20 response at week 12, compared with placebo.
 
Serious adverse events occurred in 4.7% of patients in both the Cimzia group (combined dose) and in the placebo group. The safety profile for patients with AS treated with Cimzia was similar to the safety profile seen in patients with RA and in patients with previous experience with Cimzia.

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