Leading organizations ask FDA advisory committee to consider patient needs in Alzheimer’s-delaying treatments
Published May 25, 2023
Six organizations – the Alliance, the American Academy of Neurology, Healthcare Leadership Council, LEAD Coalition, National Minority Quality Forum, and Partnership to Fight Chronic Disease – on May 25, 2023, wrote to the members of the Food & Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee in advance of their upcoming meeting to discuss traditional approval of lecanemab for the treatment of Alzheimer’s disease. While the organizations do not make a recommendation on whether the FDA should provide a traditional approval, the letter notes data from the clinical trial that is relevant to the outcomes that important to individuals living with Alzheimer’s and their caregivers.