The agency acknowledged last month that there was not convincing evidence that Aduhelm slowed patients’ cognitive decline. Instead, it based its approval on the drug’s ability to reduce levels of a protein called amyloid, which clumps into plaques in the brains of Alzheimer’s patients. But many Alzheimer’s experts have said there is not solid evidence that reducing amyloid levels has any effect on people’s cognitive problems. On Thursday, Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, said the F.D.A. Before becoming interim commissioner in January, Dr. Woodcock was the longtime leader of the arm of the agency responsible for approving drugs.

Source: New York Times July 08, 2021 17:54 UTC