The FDA has issued a complete response letter to AstraZeneca regarding its application for subcutaneous administration of Saphnelo (anifrolumab) in adults with systemic lupus erythematosus.
The application was based on a planned interim analysis of the phase 3 Tulip-SC trial, which met its primary endpoint of reducing disease activity, according to a Feb. 3 company news release. The trial enrolled 367 participants who were randomized by a 1-to-1 ratio to receive either a 120-milligram subcutaneous dose of anifrolumab or placebo via a prefilled syringe. The safety profile was consistent with intravenous Saphnelo.
AstraZeneca said it has submitted additional information requested in the FDA’s letter and expects a decision on the updated application in the first half of 2026. Saphnelo remains available in its intravenous formulation, which is approved in more than 70 countries and has been used to treat more than 40,000 patients globally.
