AstraZeneca received an FDA complete response letter for subcutaneous Saphnelo (anifrolumab) in lupus. A regulatory decision is now expected in the first half of 2026
Written By: Pharmacally Medical News Desk
AstraZeneca has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking approval of Saphnelo (anifrolumab) for subcutaneous (SC) administration in adult patients with systemic lupus erythematosus (SLE).
The company confirmed that it has now provided the additional information requested by the FDA and will continue working closely with regulators to advance the review as quickly as possible. AstraZeneca expects an FDA decision on the updated Saphnelo SC application in the first half of 2026. Saphnelo intravenous (IV) infusion remains commercially available and is not affected by this regulatory action.
Application supported by Phase III TULIP-SC interim analysis
The original BLA submission was supported by a planned interim analysis from the Phase III TULIP-SC trial, (NCT04877691) which evaluated the efficacy and safety of a subcutaneous formulation of Saphnelo for patients with moderate to severe lupus. The study met its primary endpoint, demonstrating a reduction in disease activity, while the safety findings were consistent with the established profile of the IV formulation.
EU approval already secured for Saphnelo SC
Despite the US CRL, AstraZeneca has already achieved significant regulatory progress internationally. In December 2025, the European Union approved Saphnelo SC for the treatment of adult patients with moderate to severe SLE, enabling an at-home self-administration option.
Since that approval, AstraZeneca reported that the full analysis of the TULIP-SC trial confirmed the positive interim findings. The complete results showed that subcutaneous anifrolumab successfully met its primary endpoint of reducing disease activity, with findings published in Arthritis & Rheumatology in January 2026.
Established global role of Saphnelo in lupus care
Saphnelo IV is currently approved for moderate to severe systemic lupus erythematosus in more than 70 countries, including the United States, European Union, and Japan. AstraZeneca noted that over 40,000 patients worldwide have been treated with Saphnelo to date, highlighting its growing clinical adoption.
Financial and licensing background
AstraZeneca originally acquired global rights to Saphnelo through a licensing and collaboration agreement with Medarex in 2004. Following Medarex’s acquisition by Bristol Myers Squibb in 2009, co-promotion rights expired. Under an agreement updated in 2025, AstraZeneca will pay BMS a mid-teens royalty on US sales.
For complete clinical trial insights, lupus disease background, and the full Saphnelo profile, readers can explore Pharmacally’s in-depth reports linked above.
References
Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus, 03 February 2026, Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus
Full Phase 3 TULIP-SC Results Support Self-Administered Saphnelo for Lupus, 06 January 2026, https://pharmacally.com/full-phase-3-tulip-sc-results-support-self-administered-saphnelo-for-lupus/
Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus (Tulip SC), ClinicalTrials.gov ID NCT04877691, https://clinicaltrials.gov/study/NCT04877691
Manzi, S. et al, Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: The Randomized, Phase 3, TULIP-SC Study. Arthritis & Rheumatology. https://doi.org/10.1002/art.70041