Alzheimer’s drug to be reviewed by FDA panel for first time in two decades

A new drug showing promise of slowing the mental decline of patients with Alzheimer's disease will be reviewed by a Food and Drug Administration panel on Friday to determine if it is safe and effective.

This is the first new Alzheimer's drug in two decades that the panel will review. The panel will advise the FDA on the drug based on its conclusions from the review.  

The drug, called aducanumab, comes from Cambridge, Massachusetts-based Biogen Inc. and Japan’s Eisai Co. Although it does not cure Alzheimer’s and does not reverse the effects of the disease, the company claims that the drug slows the rate of mental decline. The medicine would be given through an IV once a month.

“There is a dire and drastic need” to help people impacted “by the crushing realities” of the disease, the association wrote to the FDA. Some doctors say that any benefit from the drug would be relatively small, and the drug would be extremely expensive because it is made from living cells.

“This is a difficult decision. I think it’s going to be contentious no matter how it falls out,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation, who consults for Biogen.

Some previous studies from the company show positive results, while there have also been studies showing the drug didn’t seem to have a positive effect.

The FDA has until March to decide on approval.