The Investor
05 Feb 2026, 18:45
AstraZeneca said the US Food and Drug Administration has issued a complete response letter for the biologics license application covering subcutaneous administration of Saphnelo in systemic lupus erythematosus, but the company has already submitted the requested information and is working with regulators to advance the review.
The company expects an FDA decision in the first half of 2026, while intravenous Saphnelo remains commercially available. The update follows positive Phase III TULIP-SC trial results and comes after the European Union approved the subcutaneous formulation in December 2025, reinforcing AstraZeneca’s confidence in the therapy’s safety and efficacy profile.
The company expects an FDA decision in the first half of 2026, while intravenous Saphnelo remains commercially available. The update follows positive Phase III TULIP-SC trial results and comes after the European Union approved the subcutaneous formulation in December 2025, reinforcing AstraZeneca’s confidence in the therapy’s safety and efficacy profile.