Update on Saphnelo subcutaneous administration in systemic lupus erythematosus

The US FDA has recently issued a complete response letter regarding the Biologics License Application for Saphnelo for subcutaneous administration in adult patients with systemic lupus erythematosus. AstraZeneca subsequently provided the information requested in the CRL and is committed to working with the FDA to progress the application as quickly as possible.

Note that 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, they announced the approval of Saphnelo in the EU 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

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Related Topics and Keywords

astrazenec, lupus, SAPHNELO®, Systemic Lupus Erythematosus