FDA approves UCB's Cimzia for ankylosing spondylitis

Agency delivers complete response letter for axial spondyloarthritis

ATLANTA — The Food and Drug Administration has approved a drug made by UCB for treating a form of arthritis.

The drug maker said Friday that the FDA had approved Cimzia (certolizumab pegol) for adults with active ankylosing spondylitis, though it declined to approve the drug for axial spondyloarthritis, or axSpA. UCB said it was working with the agency to determine how to get the drug approved for axSpA.

"[Ankylosing spondylitis] is a lifelong disease that can cause pain and stiffness and, at times, can be very debilitating for people living with it," UCB EVP and chief medical officer Irish Loew-Friedrich said. "Cimzia provides an important new treatment option for people living with active AS an for rheumatologists."


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