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Cimzia injection approved by United States Food and Drug Administration.

M2 EQUITYBITES-April 1, 2019-Cimzia injection approved by United States Food and Drug Administration

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The United States Food and Drug Administration (FDA) has approved UCB's Cimzia (certolizumab pegol) injection intended for the treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis, with objective signs of inflammation, it was reported on Friday.

The efficacy of the product was studied in a randomised clinical trial in 317 adult patients with non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) levels and/or sacroiliitis (inflammation of the sacroiliac joints) on MRI.

Nikolay Nikolov, MD, associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA's Center for Drug Evaluation and Research, said, Today's approval of Cimzia fulfils an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there has been no FDA-approved treatments until now.'

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Publication:M2 EquityBites (EQB)
Date:Apr 1, 2019
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