UCB gets partial label expansion for Cimzia

FDA expanded the label of Cimzia certolizumab pegol from UCB Group (Euronext:UCB) to include treatment of adults with active ankylosing spondylitis, but the agency issued a complete response letter for active axial spondyloarthritis. UCB had been seeking to expand Cimzia's label to include treatment of active axial spondyloarthritis, including patients with ankylosing spondylitis. In July, FDA's Arthritis Advisory Committee had backed that label expansion. According to FDA briefing documents for the meeting, ankylosing spondylitis is a "well-characterized, chronic and progressive form" of axial spondyloarthritis. There are currently no approved drugs in the U.S. for axial spondyloarthritis. UCB declined to disclose the details of the complete response letter (see BioCentury Extra, July 23). ...