AstraZeneca's Saphnelo Subcutaneous Injection for Lupus Faces FDA Delay, Resubmission Under Review

On February 3, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for Saphnelo (anifrolumab) subcutaneous injection for the treatment of adult patients with systemic lupus erythematosus (SLE). AstraZeneca stated that it has provided the required supplementary information to the FDA as requested and will continue to collaborate with regulatory authorities to advance the marketing application process for this formulation.

Source: AstraZeneca Official Website

FDA Decision on Updated Saphnelo Subcutaneous Injection Application Expected in the First Half of 2026; Current Saphnelo Intravenous Formulation Remains on Market for Normal Sale.

AstraZeneca's BLA submission to the FDA is based on the interim analysis results of the Phase III TULIP-SC clinical trial, which evaluated the subcutaneous administration regimen of Saphnelo and has met the primary endpoint. The safety profile observed in the TULIP-SC trial is consistent with the known clinical safety profile of Saphnelo intravenous infusion.

In December 2025, AstraZeneca announced that the subcutaneous injection of Saphnelo has been approved in the EU for the treatment of adult patients with moderate to severe SLE. Currently, the intravenous infusion formulation of Saphnelo has been approved in more than 70 countries, including the United States, the EU, and Japan, for the treatment of moderate to severe SLE. To date, more than 40,000 patients worldwide have received Saphnelo treatment.

In 2004, AstraZeneca acquired global rights to Saphnelo through an exclusive licensing and collaboration agreement with Medarex. The co-promotion rights originally held by Medarex were terminated when it was acquired by Bristol-Myers Squibb (BMS) in 2009.