The Food and Drug Administration has approved subcutaneous tocilizumab (Actemra) for the treatment of giant cell arteritis, according to a May 22 announcement from the agency.

Giant cell arteritis is a type of vasculitis that inflames blood vessels in the head, causing arteries to narrow or become irregular. The temporal arteries are the most commonly affected blood vessels, but giant cell arteritis can also affect other large blood vessels such as the aorta. Tocilizumab is the first drug specifically intended to treat giant cell arteritis. The standard treatment has typically been high doses of corticosteroids, tapered over time.

“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,” Badrul Chowdhury, MD, PhD, director of the division of pulmonary, allergy, and rheumatology products in the FDA’s Center for Drug Evaluation and Research said in the announcement .

The FDA’s approval of tocilizumab was based on results from a double-blind, placebo-controlled study of 251 patients with giant cell arteritis. After 1 year, patients who received tocilizumab and tapered prednisone achieved remission at a higher rate than did patients who received placebo and tapered prednisone. Safety was consistent with tocilizumab’s known safety profile.

Subcutaneous tocilizumab is also approved for moderate to severely active rheumatoid arthritis. The intravenous formulation is approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis.

The FDA granted both Breakthrough Therapy and Priority Review designations to this supplemental new drug application of tocilizumab.


You May Also Like

Care bundle cut emergency laparotomy death rate by 39%

An evidence-based care bundle implemented in four U.K. hospitals almost doubled the proportion of ...

Meta-analysis suggests earlier twin delivery to prevent stillbirth

FROM BMJ Delivery for uncomplicated dichorionic twin pregnancies should be considered at 37 weeks’ ...

CORRECTION: Ask patients about military service, lawyers urge

An article titled “Ask patients about military service, lawyers urge“ (published January 4, 2016) ...