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FDA Approves First Drug to Treat Giant Cell Arteritis

FDA news release; 2017 May 22

Publish date:: June 5, 2017

The US Food and Drug Administration (FDA) has expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis (GCA). The FDA granted the supplemental approval of Actemra to Hoffman La Roche Inc., the manufacturer of the drug.

Indication: Actemra is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of GCA, as well as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systematic juvenile idiopathic arthritis. This new indication for GCA provides the first FDA-approved therapy specific to this type of vasculitis.

Dosage/administration: The recommended dose of Actemra for adult patients with GCA is 162 mg given once every week as a subcutaneous injection, in combination with a tapering course of glucocorticoids. A dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations. Intravenous administration is not approved for GCA.

Adverse effects: Most common adverse reactions include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and injection site reactions.

Citation:

US Food and Drug Administration. FDA approves first drug to specifically treat giant cell arteritis. FDA Web site, May 22, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm559791.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed May 30, 2017.

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