Saphnelo subcutaneous formulation application rejected by FDA, AstraZeneca: committed to closely cooperate with FDA to expedite application.

AstraZeneca announced on February 3 that the US Food and Drug Administration (FDA) has issued a complete response letter for the biologics license application of Saphnelo for subcutaneous administration in adult patients with systemic lupus erythematosus. AstraZeneca subsequently provided the supplemental information requested in the complete response letter and pledged to work closely with the FDA to expedite the application. The FDA is expected to make a decision on the updated Saphnelo application in the first half of 2026. The intravenous formulation of Saphnelo can still be marketed and sold as usual. On the same day, the FDA rejected AstraZeneca's application for the self-injection formulation of the lupus treatment drug.