AstraZeneca has announced its drug Saphnelo (anifrolumab-fnia)—a first-in-class type I interferon receptor antibody—has landed approval by the US Food and Drug Administration (FDA). According to the pharmaceutical firm, the treatment is the first novel treatment for systemic lupus erythematosus (SLE) to receive the go-ahead from the agency in more than 10 years.
The FDA reportedly based its approval on the efficacy and safety data from the Saphnelo clinical development program, including two TULIP Phase III trials and the MUSE Phase II trial. In the trials, results indicate more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid (OCS) use compared to placebo, with both groups receiving standard therapy.
The approval is the first for a type I interferon (type I IFN) receptor antagonist. Type I IFN plays a central role in the pathophysiology of lupus and increased type I IFN signaling is associated with increased disease activity and severity.
Richard Furie (chief of the Division of Rheumatology at Northwell Health and a principal investigator in the Saphnelo clinical development program) said the approval offers a ray of hope for lupus patients worldwide.
“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,” Furie commented. “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.”