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FDA approves Saphnelo for moderate to severe systemic lupus erythematosus

Posted on August 3, 2021
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The U.S. Food and Drug Administration has approved anifrolumab-fnia (Saphnelo; AstraZeneca), a first-in-class type I interferon receptor antagonist for adults with moderate to severe systemic lupus erythematosus (SLE), according to a press release.

This is the first new treatment for SLE in more than 10 years.

Approval was based on efficacy and safety data from the TULIP Phase 3 trials and the MUSE Phase 2 trial, in which more patients with SLE treated with anifrolumab had a reduction in overall disease activity across multiple organ systems and a sustained reduction in oral corticosteroid (OCS) use compared to placebo.

“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 Dr Richard Furie, Chief of the Division of Rheumatology at Northwell Health, New York, US and a principal investigator in the Saphnelo clinical development programme, in a press release.

Read the full press release here.

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