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Pharmaceuticals / Submissions and Approvals

FDA Approves Cimzia for Treatment of Nr-axSpA Inflammatory Arthritis

April 8, 2019
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The FDA approved UCB’s Cimzia (certolizumab pegol) injection for treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA)—a condition that causes inflammation of the spine that is not visible on x-rays.

Cimzia showed efficacy in a randomized clinical trial in 317 adult patients with nr-axSpA with objective signs of inflammation, including elevated C-reactive protein levels or inflammation of the sacroiliac joints visible on an MRI scan.

Cimzia requires a boxed warning about the increased risk of serious infections leading to hospitalization or death, including tuberculosis, infection in the blood steam, invasive fungal infections and other infections.

Originally approved in 2008, the drug also is indicated for adult patients with Crohn’s disease, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis (AS) and moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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