The US Food and Drug Administration (FDA) has expanded the approved use of subcutaneous tocilizumab (Actemra, Hoffman LaRoche) to include treatment of adults with giant cell arteritis. This will be the first FDA-approved therapy specific to the disorder.
Tocilizumab is a humanized monoclonal antibody that targets the interleukin-6 receptor.
The FDA granted a Breakthrough Therapy designation and a Priority Review for tocilizumab for this indication.
"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 an FDA news release.
The decision follows consideration of data from a double-blind, placebo-controlled trial that included 251 patients with giant cell arteritis.
A greater proportion of patients who received subcutaneous tocilizumab with standardized prednisone regimens achieved sustained remission from week 12 through week 52 — the primary efficacy endpoint — compared with those who received placebo with standardized prednisone regimens. The researchers defined sustained remission as the absence of giant cell arteritis symptoms, normalization of inflammatory laboratory tests, and tapering the use of prednisone. The cumulative prednisone dose was lower in patients who received tocilizumab than in those who received placebo.
The overall safety profile in patients who received tocilizumab for this indication was "generally consistent" with the known safety profile of tocilizumab, the FDA reports in the news release. Tocilizumab has a Boxed Warning for serious infections.
Patients using tocilizumab who develop a serious infection should discontinue tocilizumab until the infection is under control. Patients undergoing tocilizumab treatment should avoid live vaccines during treatment. Tocilizumab should be used cautiously in patients with increased risk for gastrointestinal perforation.
There are reports of hypersensitivity reactions, including anaphylaxis and death, in patients using tocilizumab. Tocilizumab recipients should undergo laboratory monitoring because treatment-related changes in neutrophils, platelets, lipids, and liver function test results are possible.
The FDA previously approved tocilizumab for subcutaneous use in patients with moderately to severely active rheumatoid arthritis. The agency also previously approved tocilizumab for intravenous use in patients with moderately to severely active rheumatoid arthritis, systemic juvenile idiopathic arthritis, and polyarticular juvenile idiopathic arthritis. Tocilizumab is not approved for intravenous use in patients with giant cell arteritis.
Giant cell arteritis is a type of vasculitis that causes arteries to become narrow or irregular, disrupting blood flow. It occurs mostly in the arteries of the head — particularly the temporal arteries — but can also cause inflammation in other blood vessels, including the aorta. It is sometimes referred to as temporal arteritis.
Standard treatment of giant cell arteritis consists of high doses of corticosteroids that are gradually tapered.
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Cite this: FDA Approves Tocilizumab (Actemra) for Giant Cell Arteritis - Medscape - May 22, 2017.
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