股价一度跌近2%！阿斯利康(AZN.US)狼疮药自行注射剂型申请遭FDA驳回

Core Viewpoint - The FDA has rejected AstraZeneca's application for a self-injection version of its lupus treatment drug, Saphnelo, but the company is still in communication with the regulatory agency to advance the approval process [1] Group 1: Company Actions - AstraZeneca has submitted the required information in response to the FDA's complete response letter and is committed to expediting the application process [1] - The company experienced a 1.9% drop in its stock price in London following the news, nearly erasing its annual gains [1] Group 2: Product Information - Saphnelo is currently approved in an intravenous form, requiring patients to visit hospitals or clinics for treatment every four weeks [1] - The self-injection version, if approved, would allow patients to administer the drug weekly [1] - Analysts predict that Saphnelo could achieve annual revenues exceeding $1.6 billion by 2031 [1] Group 3: Market Context - Systemic lupus erythematosus, the condition treated by Saphnelo, affects over 3.4 million patients globally [1] - The European Union approved the subcutaneous injection form of Saphnelo in December of the previous year [1] - A late-stage clinical trial indicated that the self-injection version effectively reduces disease severity compared to a placebo [1] Group 4: Regulatory Timeline - The FDA is expected to make a decision on AstraZeneca's supplemental application in the first half of this year, during which the intravenous form of the drug will remain available [2]