Alzheimer’s is a complex and frustrating disease that robs people of their memories and families of their loved ones.
Statement on FDA Draft Guidance for Alzheimer’s Drug Development
Published February 7, 2013
Washington, D.C. (February 7, 2013) – Today Daniel Perry, President and CEO of the Alliance for Aging Research and Chairman of the Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD) coalition released the following statement in response to guidance from the U.S. Food and Drug Administration (FDA) on the development of drugs for Alzheimer’s Disease.
“FDA’s release of long-awaited guidance on Alzheimer’s drug development demonstrates the Agency’s continued commitment to being a partner in bringing therapies to patients. With reports yesterday that the number of Alzheimer’s diagnoses may triple by 2050, we all must work effectively and hastily toward a common goal of stopping this diseases at the earliest possible point in its progression.
We are encouraged by FDA’s public recognition that previous requirements to show change on both a cognitive and functional scale to measure the effect of a treatment are difficult to apply in people with early stages of Alzheimer’s and that in some cases the Agency is open to accepting changes on a reliable cognitive measure for initial approval.
We are disappointed by the Agency’s current assessment that evidence does not support the use of biomarkers as a primary surrogate outcome measures for demonstrating disease modification but we hope that this will serve as a call to the research community and industry to work more aggressively toward establishing widespread and robust consensus around the validity of biomarkers for this purpose.”
FDA will be accepting comments on the draft guidance for 60 days. The ACT-AD coalition will be submitting detailed comments to the Agency to inform the final guidance.
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About the Alliance for Aging Research Founded in 1986, the Alliance for Aging Research (Alliance) is a nonprofit, independent organization dedicated to improving the health and independence of aging Americans through public and private funding of medical research and geriatric education. The Alliance combines the interest of top scientists, public officials, business executives, and foundation leaders to promote a greater national investment in research and new technologies that will prepare our nation for the coming senior boom, and improve the quality of life for today’s older generation. For more information, visit: www.agingresearch.org.