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This is the first new approval for lupus in a decade.
The FDA has approved Saphnelo (anifrolumab-fnia) for the treatment of adult patients with moderate-to-severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
The agency's OK marks the first regulatory approval for a type I interferon (type I IFN) receptor antagonist and the first new treatment approved for SLE in more than decade.
The FDA's approval is based on efficacy and safety data from several clinical trials, including two phase 3 trials and one phase 2 trial. In those trials, more patients treated with Saphnelo compared with those treated with a placebo were more likely to experience a reduction in overall disease activity across organ systems — including skin and joints — and achieved sustained reduction in oral corticosteroid use. In the trials. The trials were designed so that both the Saphnelo and the placebo groups were also treated with standard therapy.
Results from the TULIP-2 phase 3 trial were published in The New England Journal of Medicine in January 2020, results from the TULIP-1 phase 3 trial were published in The Lancet Rheumatology in December 2019, and results from the MUSE phase 2 trial were published in Arthritis & Rheumatology in November 2016.
“Our treatment goals in systemic lupus erythematosus are to reduce disease activity, prevent organ damage from either the illness itself or the medications, especially steroids, and improve one’s quality of life,” Richard A. Furie, M.D., chief of the division of rheumatology at Northwell Health in New York, said in a statement. “Today’s approval of anifrolumab represents a big step forward for the entire lupus community. Physicians will now be able to offer an effective new treatment that has produced significant improvements in overall disease activity, while reducing corticosteroid use.”
The Lupus Foundation of America estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus. About 90% of the people living with lupus are women. The disease typically first occurs between ages of 15 and 44.