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04-08-2021 | Systemic lupus erythematosus | News

FDA approves anifrolumab for moderate-to-severe SLE

Author:
Claire Barnard

medwireNews: The US FDA has approved anifrolumab-fnia for the treatment of adult patients with moderate-to-severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

This approval is based on the results of the phase 3 TULIP-1 and TULIP-2 trials, and the phase 2 MUSE trial, which showed an overall reduction in disease activity across organ systems and reduction in corticosteroid use compared with placebo, despite the TULIP-1 trial not meeting its primary endpoint.

Click through to read about the TULIP-1 and TULIP-2 trial results

The type I interferon receptor antagonist is approved for intravenous use at a dose of 300 mg every 4 weeks. The FDA cautions that anifrolumab-fnia has not been evaluated in people with severe active lupus nephritis or severe active central nervous system lupus, and it is not recommended for use in these patient populations.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

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