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AUGUST 4, 2021

FDA Approves Saphnelo, First New Treatment for Lupus in 10 Years

By SPC News Staff
The FDA approved anifrolumab-fnia (Saphnelo, AstraZeneca), a first-in-class treatment for adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

This marks the first regulatory approval for a type I interferon (type I IFN) receptor antagonist and the only new treatment approved for SLE in more than 10 years. Type I IFN plays a central role in the pathophysiology of lupus. Increased type I IFN signaling is associated with increased