Actemra Approved for Certain Blood Vessel Inflammation
MONDAY, May 22, 2017 -- The injected drug Actemra (tocilizumab) has been approved by the U.S. Food and Drug Administration to treat adults with giant cell arteritis, an inflammation of the blood vessels (vasculitis).
In a media release Monday, the FDA said this form of vasculitis mostly involves blood vessels of the head. Traditional therapy includes large doses of anti-inflammatory drugs called corticosteroids.
"We expedited the development and review of this application because [Actemra] fulfills a critical need for patients with this serious disease who had limited treatment options," said Dr. Badrul Chowdhury, director of the agency's Division of Pulmonary, Allergy, and Rheumatology Products.
Actemra was evaluated in clinical studies involving 251 people with giant cell arteritis. The drug will carry a boxed label warning of the possibility of serious infections. For that reason, live vaccines should be avoided while taking the drug, the FDA said.
And Actemra should be used "with caution" among people at increased risk of gastrointestinal perforation or dangerous allergic-like hypersensitivity reactions, the agency added.
The Hoffman La Roche drug was first approved in 2010 for moderately-to-severely active rheumatoid arthritis. The company is based in Basel, Switzerland.
Learn more from the FDA.
Posted: May 2017