Washington D.C., Mar. 08, 2024- The U.S. Food and Drug Administration (FDA) announced today that it expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of Donanemab in early symptomatic Alzheimer’s disease. As the FDA is the federal agency Congress entrusted with the duty to ensure that therapies approved for use in the United States are safe and effective for patients, the Global Alzheimer’s Platform Foundation® (GAP) encourages the FDA to conclude its review of Donanemab thoroughly and expeditiously.
John Dwyer, the President of GAP stated: “Today, the FDA extended its time to review the data demonstrating the safety and efficacy of Donanemab. The Global Alzheimer’s Platform Foundation supports a thorough review of the therapy’s performance; patients deserve nothing less. We also expect the FDA to convene the meeting of the PCNS as soon as possible and to expeditiously conclude the approval process because every day thousands of patients afflicted with Alzheimer’s disease are progressing beyond the point of benefiting from this disease modifying therapy.”
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For immediate release:
Contact: media@globalalzplatform.org
About the Global Alzheimer’s Platform (GAP) Foundation:
The nonprofit Global Alzheimer’s Platform Foundation was founded to speed the delivery of Alzheimer’s treatments with a commitment to promoting diversity in clinical research, as well as lowering the cost and duration of clinical trials to ensure that no one is left behind. As part of its mission, GAP supports more than 100 clinical research sites worldwide through study start-up and recruitment activities, promoting diversity in research studies, and giving attention to the citizen scientists who make research possible.