LONDON (dpa-AFX) - AstraZeneca PLC (AZN) on Tuesday said the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics License Application (BLA) for Saphnelo for subcutaneous administration in adults with systemic lupus erythematosus (SLE).
The company said it has since provided the additional information requested by the FDA in the CRL.
A regulatory decision on the updated application for the subcutaneous formulation of Saphnelo is expected in the first half of 2026.
The original BLA submission was based on an interim analysis of the Phase III TULIP-SC trial, which evaluated subcutaneous administration of Saphnelo and met its primary endpoint. AstraZeneca said the safety profile observed in the study was consistent with the known clinical profile of Saphnelo administered as an intravenous infusion.
In December 2025, Saphnelo was approved in the European Union for subcutaneous use in adults with moderate to severe SLE.
The intravenous formulation of Saphnelo is currently approved for the treatment of moderate to severe SLE in more than 70 countries worldwide, including the United States, the European Union and Japan.
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