Subcutaneous tocilizumab (marketed as Actemra by Hoffman La Roche) has been approved by the US drug safety watchdog to treat adults with giant cell arteritis, a type of vasculitis.
It is the first drug of its kind to be made available by the Food and Drug Administration (FDA) to treat adults with this condition, although it is already available in the United States in the same form for patients with severely active rheumatoid arthritis.
Announcing the decision, Badrul Chowdhury, director of the division of pulmonary, allergy, and rheumatology products at the FDA Center for Drug Evaluation and Research, says: “We expedited the development and review of this application because this drug fulfils a critical need for patients with this serious disease who had limited treatment options.”
The decision follows the results of a double-blind, placebo-controlled study which involved 251 patients with giant cell arteritis. Researchers looked for sustained remission from the disease from week 12 to week 52.
They found that a greater proportion of patients receiving subcutaneous tocilizumab along with standardized prednisone regimens, achieved sustained remission compared to patients receiving placebo with standardized prednisone regimens.
The FDA points out tocilizumab has a boxed warning for serious infections. Patients treated with the product who develop a serious infection should stop that treatment until the infection is controlled. Live vaccines should also be avoided during drug treatment, it recommends.
The product was designated breakthrough therapy status by the FDA and was given a priority review in recognition of its potential to treat a serious condition and offer “significant” improvement.