The US Food and Drug Administration (FDA) recently communicated its decision on AstraZeneca plc.'s Biologics License Application (BLA) for the subcutaneous formulation of Saphnelo (anifrolumab), intended to treat systemic lupus erythematosus (SLE). On Tuesday, the FDA issued a complete response letter (CRL) indicating that the agency requires additional information to proceed with approval.
In response to the CRL, AstraZeneca promptly provided the requested supplementary data to support its application. The company now anticipates a regulatory decision on the updated Saphnelo SC application within the first half of 2026. It is important to note that the intravenous (IV) form of Saphnelo continues to be commercially available for patients.
The initial BLA submission for Saphnelo SC was grounded in intermediate results from the Phase 3 TULIP-SC clinical trial. This study evaluated the efficacy and safety of subcutaneously administered Saphnelo in individuals diagnosed with systemic lupus erythematosus. In the trial's interim analysis, the subcutaneous administration met its primary efficacy endpoint.
In clinical terms, treatment with Saphnelo via the subcutaneous route demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo. Specifically, the full analysis of the TULIP-SC trial revealed that 56.2% of patients receiving Saphnelo experienced a reduction in disease activity at Week 52, compared with 37.1% in the placebo group. These results were consistent with outcomes observed in prior studies of Saphnelo.
Regarding safety, the profile of Saphnelo in the TULIP-SC trial aligned with the known clinical experience associated with intravenous administration. There were no unexpected safety concerns or adverse events reported that diverged from the anticipated effects based on the intravenous formulation's profile.
In December 2025, AstraZeneca announced that regulatory authorities in the European Union approved Saphnelo for subcutaneous administration in adult patients with moderate to severe systemic lupus erythematosus. This approval reflects recognition of the drug’s efficacy and safety in this patient population across key global markets.
In a related development, AstraZeneca, in collaboration with Daiichi Sankyo, received FDA acceptance and Priority Review designation for their supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan). This application concerns treatment for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor therapies.
The regulatory action date under the Prescription Drug User Fee Act (PDUFA) is projected for the second quarter of 2026, marking when the FDA is expected to issue its decision on the supplemental application.
The sBLA submission is supported by data from the TROPION-Breast02 Phase 3 trial. In this study, Datroway demonstrated a statistically significant and clinically meaningful improvement in median overall survival by 5.0 months compared to chemotherapy, concurrently reducing the risk of disease progression or death by 43% in first-line treatment of the target patient population.
Additional findings from TROPION-Breast02 showed durable treatment effects for Datroway, including an objective response rate (ORR) of 62.5% and a duration of response (DoR) lasting 12.3 months. These outcomes contrasted favorably with chemotherapy, which achieved an ORR of 29.3% and a DoR of 7.1 months.
From a market perspective, AstraZeneca’s shares experienced a modest increase of 0.67% during premarket trading, reaching $189.67 as of the latest reported session on Tuesday, according to Benzinga Pro data.
The developments represent significant regulatory and clinical milestones for AstraZeneca’s portfolio, influencing its presence in both autoimmune and oncology therapeutic areas. The pending FDA decisions in 2026 will be closely watched by investors and industry observers for their potential impact on the company’s future commercial prospects.
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