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% of patients who received Saphnelo achieved a reduction in disease activity at Week 52 versus 37.1% receiving placebo, which was consistent with results from previous trials.
The safety profile observed in the TULIP-SC trial was consistent with the known clinical profile of Saphnelo administered as an intravenous (IV) infusion.
In December 2025, AstraZeneca announced the approval of Saphnelo in the European Union (EU) for subcutaneous administration in adult patients with moderate to severe SLE.
Priority Review For Datroway For Breast Cancer
AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) has been accepted and granted Priority Review in the US for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the second quarter of 2026.
The sBLA is based on results from the TROPION-Breast02 Phase 3 trial, which showed Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival, and a 43% reduction in patients' risk of disease progression or death compared to chemotherapy as 1st-line treatment in this patient population.
Datroway was also associated with durable treatment responses, including an objective response rate (ORR) of 62.5% and duration of response (DoR) of 12.3 months, compared to an ORR of 29.3% and DoR of 7.1 months with chemotherapy.
Price Action: AZN stock is up 0.67% at $189.67 during the premarket session at the last check on Tuesday, according to Benzinga Pro data.
Photo via Shutterstock
