The US FDA has issued a complete response letter for global pharma giant AstraZeneca’s Biologics License Application seeking approval of Saphnelo (anifrolumab) for subcutaneous administration in adults with systemic lupus erythematosus.

 

In response, AstraZeneca confirmed it has “provided the information requested in the CRL and is committed to working with the FDA to progress the application as quickly as possible.”

 

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available.

 

The original BLA was based on a planned interim analysis of the Phase III TULIP-SC trial, which evaluated Saphnelo’s subcutaneous administration and “met the primary endpoint.” AstraZeneca noted that “the safety profile observed in the TULIP-SC trial was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.”

 

AstraZeneca also highlighted its recent European success. In December 2025, Saphnelo was approved in the EU for subcutaneous use in adults with moderate to severe SLE. The full TULIP-SC analysis subsequently “demonstrated the subcutaneous administration of Saphnelo met the primary endpoint of reduction in disease activity,” with results published in Arthritis & Rheumatology in January 2026.

 

Saphnelo IV infusion is already approved for moderate to severe SLE in more than 70 countries worldwide, including the US, EU, and Japan, with over 40,000 patients treated globally to date.