FDA expanded on Monday the approved use of subcutaneous tocilizumab (Actemra—Hoffman La Roche) to treat adults with giant cell arteritis, providing 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, MD, PhD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in FDA's Center for Drug Evaluation and Research. A double-blind, placebo-controlled study involving 251 patients was used to demonstrate the efficacy and safety of subcutaneous tocilizumab for giant cell arteritis. The data showed that a greater proportion of patients receiving subcutaneous tocilizumab with standardized prednisone regiments achieved sustained remission from week 12 through week 52 compared with patients receiving placebo with standardized prednisone regimens. Additionally, the cumulative prednisone dose was lower in treated patients with tocilizumab relative to placebo. FDA notes the overall safety profile observed in the tocilizumab treatment groups was generally consistent with the known safety profile of tocilizumab. The drug carries a boxed warning for serious infections. Live vaccines should be avoided during treatment with tocilizumab. Hypersensitivity reactions, including anaphylaxis and death, have occurred. Lab monitoring is recommended due to possible consequences of treatment-related changes in neutrophiles, platelets, lipids, and liver function tests. Subcutaneous tocilizumab was previously approved for the treatment of moderate to severely active rheumatoid arthritis, while I.V. tocilizumab was also previously approved for the treatment of moderate to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis.