FDA加速批准渤健阿尔茨海默药上市引争议，药物后期临床效益仍需验证

Core Viewpoint - The FDA has approved Aduhelm (Aducanumab) for the treatment of early Alzheimer's disease, marking the first approval of an Alzheimer's drug since 2003, despite controversies surrounding its clinical trial data and efficacy [1] Group 1: FDA Approval - The approval of Aduhelm is seen as a significant development for Alzheimer's patients, providing a new treatment option [1] - The decision has sparked debate due to the drug's bypassing of phase II trials and the contradictory results from its clinical studies [1] Group 2: Regulatory Requirements - The FDA has mandated that the manufacturer, Biogen, conduct new randomized controlled trials to confirm the clinical benefits of Aduhelm under the "accelerated approval" pathway [1] - If the new trials fail to validate the drug's clinical efficacy, the FDA may initiate procedures to revoke its approval [1]