Tocilizumab approved for giant cell arteritis
medwireNews: The US FDA has approved subcutaneous tocilizumab for the treatment of giant cell arteritis, providing the first FDA-approved therapy specific to this condition.
The interleukin-6 inhibitor was granted a Breakthrough Therapy designation and a Priority Review because it “fulfills a critical need for patients with this serious disease who had limited treatment options,” said Badrul Chowdhury, from the FDA Center for Drug Evaluation and Research, in a news release.
Subcutaneous tocilizumab was previously approved for the treatment of moderate to severely active rheumatoid arthritis.
The accelerated approval for giant cell arteritis was based on the results of a randomized controlled trial showing that a higher proportion of patients receiving tocilizumab alongside prednisone achieved sustained remission compared with those receiving placebo plus prednisone.
The label for tocilizumab carries a boxed warning for serious infections, and live vaccines should be avoided during treatment, the FDA says.
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