Trials & Filings

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 o...

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