The US Food and Drug Administration (FDA) has approved the tumor necrosis factor inhibitor certolizumab pegol (Cimzia, UCB Pharma) for treatment of adults with active ankylosing spondylitis (AS), the company said in a news release.
"AS is a lifelong disease that can cause pain and stiffness and at times can be very debilitating for people living with it," Iris Loew-Friedrich, MD, PhD, UCB's chief medical officer and executive vice president, said in the release.
Certolizumab pegol "provides an important new treatment option for people living with active AS and for rheumatologists," Dr. Loew-Friedrich said.
The approval of certolizumab for adults with active AS was based on a phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of the drug in patients with active axial spondyloarthritis, the majority of whom had AS, the company said.
The company also reported receiving a complete response letter from the FDA relating to the supplemental Biologics License Application of certolizumab pegol for adults with active axial spondyloarthritis.
In July 2013, the FDA's Arthritis Advisory Committee voted narrowly for the approval of certolizumab pegol for this indication, as reported by Medscape Medical News.
Certolizumab is already approved in the United States for the treatment of adults with moderate to severe rheumatoid arthritis and for reducing signs and symptoms of moderately to severely active Crohn's disease in adults who have not been helped by conventional therapy.
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Cite this: FDA Clears Certolizumab (Cimzia) for Ankylosing Spondylitis - Medscape - Oct 18, 2013.