Saphnelo皮下剂型申请遭FDA驳回，阿斯利康：承诺与FDA密切合作以尽快推进申请

Core Viewpoint - AstraZeneca announced that the FDA issued a Complete Response Letter (CRL) regarding the biologics license application for Saphnelo for subcutaneous administration in adult patients with systemic lupus erythematosus [1] Group 1: FDA Response - The FDA has requested additional information from AstraZeneca, which the company has provided, and they are committed to working closely with the FDA to expedite the application process [1] - The FDA is expected to make a decision on the updated Saphnelo application in the first half of 2026 [1] Group 2: Product Availability - The intravenous formulation of Saphnelo remains available for normal market sales [1] - The FDA has rejected AstraZeneca's application for the self-injectable form of the lupus treatment [1]