FDA Alzheimer’s drug approval is a ‘triumph’

CHICAGO --- Aducanumab, the controversial new Alzheimer’s disease drug from Biogen, was just approved for clinical use by the U.S. the Food & Drug administration. The drug sticks to amyloid plaques, a characteristic of Alzheimer’s, and removes them from the brain.

“It’s a triumph for the field of research and something that the Alzheimer’s disease families and the entire research community has been waiting for,” said Dr. Marsel Mesulam, director of Northwestern’s Cognitive Neurology and Alzhemier’s Disease Center.

“But there are also quite a number of negatives that need to be kept in mind. Initially, the FDA advisory board proposed the drug not be approved because the science was not convincing. The results numerically were not convincing, because in two trials one seemed to be failing; one seemed to have a positive signal, but it was low. 

“The delay of progression in the disease was in order of 23%. That’s a low number. This is not a medication of the type that would make a paradigm shift in Alzheimer’s. 

“On the other hand, the last time we had a drug approved for Alzheimer’s was 13 years ago, so this is a huge milestone just by itself. It gives us hope and motivation to continue work. Hopefully we’ll see better results when larger populations are exposed to the drug.”