The US Food and Drug Administration (FDA) on Tuesday issued a complete response letter (CRL) regarding AstraZeneca plc.’s (NYSE:AZN) Biologics License Application (BLA) for Saphnelo (anifrolumab) for subcutaneous administration for systemic lupus erythematosus (SLE).

AstraZeneca subsequently provided the information requested in the CRL.

A decision from the FDA on the updated application for Saphnelo SC is expected in the first half of 2026. Intravenous (IV) Saphnelo remains commercially available.

The original BLA submitted to the FDA by AstraZeneca was based on a planned interim analysis of the Phase 3 TULIP-SC trial evaluating the subcutaneous administration of Saphnelo, which met the primary endpoint.

Subcutaneous (SC) administration of Saphnelo (anifrolumab) showed a statistically significant and clinically meaningful reduction in disease activity compared to placebo.

In the TULIP-SC full analysis, 56.2% ...