Posted by Michael Wonder on 22 May 2017
FDA approves first drug to specifically treat giant cell arteritis
22 May 2017 - The U.S. FDA today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis.
“We expedited the development and review of this application because this drug fulfills a critical need for patients with this serious disease who had limited treatment options,” said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
The FDA granted this application a breakthrough therapy designation and a priority review.
