FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Expands Actemra Indication to Treat Giant Cell Arteritis

May 25, 2017

The FDA has expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis.

Giant cell arteritis is a form of vasculitis, a group of disorders that cause inflammation of blood vessels. Clinical results showed patients achieving sustained remission from week 12 through week 52.

Roche’s Actemra was previously approved for the treatment of moderate to severely active rheumatoid arthritis. The FDA granted this application a Breakthrough Therapy designation and priority review. Actemra carries a boxed warning for serious infections.

View today's stories