FDA Approves First Drug for Specific Form of Vasculitis

The FDA has approved the use of subcutaneous Actemra (tocilizumab) for the treatment of adults with giant cell arteritis. This is the first FDA-approved drug specifically for the treatment of this form of vasculitis.

The safety and efficacy of the injection was examined in a double-blind, placebo-controlled study of 251 patients with giant cell arteritis. Sustained remission from week 12 to week 52 was the primary endpoint of the study. Overall, a larger amount of patients receiving Actemra with standardized prednisone regimens achieved sustained remission as compared to patients who received placebo. The safety profile observed in the study was generally consistent with the known safety profile of Actemra, which carries a boxed warning for serious infections.
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Subcutaneous Actemra was previously approved for the treatment of severely active rheumatoid arthritis and intravenous Actemra was approved for systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis.

—Michael Potts

Reference:

FDA approves first drug to specifically treat giant cell arteritis [published online May 22, 2017]. FDA. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm559791.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.