FDA Approves First Treatment for Certain Inflammatory Arthritis

The US Food and Drug Administration has approved Cimzia (certolizumab pegol) injection for the treatment of adults with non-radiographic axial spondyloarthritis with objective signs of inflammation.

The approval comes after results were published from a randomized clinical trial of 317 adult patients with non-radiographic axial spondyloarthritis with objective signs of inflammation. The trial assessed improvement responses on the Ankylosing Spondylitis Disease Activity Score; responses to the scoring system were higher for participants who received with Cimzia compared with placebo.

A boxed warning for Cimzia states that the drug can increase the risk of serious infections including tuberculosis, bacterial sepsis, and invasive fungal infections. 

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

—Melinda Stevens

Reference:

FDA approves treatment for patients with a type of inflammatory arthritis [press release]. Silver Spring, MD: US Food and Drug Administration; March 28,2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634671.htm. Accessed March 28, 2019.