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.
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.
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