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FDA Advisors Recommend Approval of Cimzia (Certolizumab Pegol) for Treatment of Spondyloarthritis
By a narrow 7-to-6 vote, with one abstention, the FDA’s Arthritis Advisory Committee has recommended the approval of a supplemental biologics license application (sBLA) for Cimzia (certolizumab pegol, UCB) for the proposed indication of the treatment of adults with active axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS).
The FDA is not bound by the committee’s guidance but may consider its recommendations during formal review of the sBLA.
The Arthritis Advisory Committee also voted on two other points regarding the data on Cimzia for the treatment of active axSpA, including patients with AS. The committee voted 8 to 5, with one member abstaining, that the data provide substantial evidence for a clinically meaningful beneficial effect of Cimzia in the treatment of axSpA, including patients with AS. The committee also voted 13 to 1 that the safety profile of Cimzia is adequate to support approval for the treatment of active axSpA, including patients with AS.
In the U.S., Cimzia (certolizumab pegol) is approved for the treatment of adults with moderately to severely active rheumatoid arthritis. It is also approved for reducing the signs and symptoms of Crohn’s disease and for maintaining a clinical response in adult patients with moderately to severely active disease that has shown an inadequate response to conventional therapy.
SpA encompasses a spectrum of inflammatory diseases that affect the spine, peripheral joints, ligaments, tendons, and other extra-articular tissues, such as the eyes, skin, and gut. SpA can be divided into peripheral and axial spondyloarthritis (axSpA), depending on the location of the predominant features. While axSpA mostly affects the spine and sacroiliac joints, peripheral SpA predominantly affects the peripheral joints. axSpA can be further divided into ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA), depending on the presence or absence of definitive changes on x-ray in the sacroiliac joints.
Source: UCB; July 24, 2013.