FDA Approves AstraZeneca’s Lupus mAb, Saphnelo

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FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

On Aug. 2, 2021, AstraZeneca announced that FDA approved Saphnelo (anifrolumab-fnia), a type I interferon (type I IFN) receptor antagonist, for treating moderate to severe systemic lupus erythematosus (SLE) in adult patients who are receiving standard therapy. The approval was based on efficacy and safety data from Phase III and Phase II trials.

The clinical trials showed that patients treated with Saphnelo experienced a reduction in disease activity across organ systems, including skin and joints. The patients further achieved sustained reduction in oral corticosteroid use compared to placebo.

According to AstraZeneca, the approval of Saphnelo marks the first regulatory approval for a type I IFN receptor antagonist. The approval also marks the first new treatment for SLE in more than 10 years, the company stated in a press release. Saphnelo is also under regulatory review for SLE in the European Union and Japan. AstraZeneca has initiated testing the drug using subcutaneous delivery in a Phase III trial in SLE and plans to start additional Phase III trials in lupus nephritis, cutaneous lupus erythematosus, and myositis.

AstraZeneca acquired the global rights to Saphnelo via an exclusive license and collaboration agreement with Medarex in 2004, but an option for Medarex to co-promote the product expired when it was acquired by Bristol-Myers Squibb (BMS) in 2009. Instead, by agreement, AstraZeneca will pay BMS a royalty for sales dependent on geography.


“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. 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,” said Richard Furie, chief of the Division of Rheumatology at Northwell Health, New York, US, and a principal investigator in the Saphnelo clinical development program, in the press release.

“Today’s landmark approval of Saphnelo is the culmination of years of AstraZeneca’s pioneering research in the type I interferon pathway, a central driver in systemic lupus erythematosus pathophysiology. This ground-breaking medicine has the potential to meaningfully improve the lives of patients living with this often debilitating disease,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, AstraZeneca, in the press release.

Source: AstraZeneca