AstraZeneca reports FDA issued CRL for BLA for subcutaneous Saphnelo

The U.S. Food and Drug Administration issued a complete response letter regarding the Biologics License Application for Saphnelo for subcutaneous administration in adult patients with systemic lupus erythematosus and AstraZeneca (AZN) subsequently provided the information requested in the CRL and is committed to working with the FDA to progress the application as quickly as possible, the company announced. “A decision from the FDA on the updated application for Saphnelo SC is expected in the first half of 2026. Intravenous Saphnelo remains commercially available. The original BLA submitted to the FDA by AstraZeneca was based on a planned interim analysis of the Phase III TULIP-SC trial evaluating the subcutaneous administration of Saphnelo, which met the primary endpoint. The safety profile observed in the TULIP-SC trial was consistent with the known clinical profile of Saphnelo administered as an intravenous infusion. In December 2025, AstraZeneca announced the approval of Saphnelo in the European Union for subcutaneous administration in adult patients with moderate to severe SLE. Since then, the full analysis of the TULIP-SC trial also demonstrated the subcutaneous administration of Saphnelo met the primary endpoint of reduction in disease activity. These results were published in Arthritis & Rheumatology in January 2026. Saphnelo IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries worldwide including the US, EU and Japan. To date, more than 40,000 patients globally have been treated with Saphnelo. AstraZeneca acquired global rights toSaphnelothrough an exclusive license and collaboration agreement with Medarex, Inc. in 2004. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMY) in 2009. Under the agreement, updated in 2025, AstraZeneca will pay BMS a mid-teens royalty for sales in the US,” the company stated.