Biogen and its Japanese partner Eisai announced Monday evening the start of an application process that will seek a fast U.S. approval for an experimental treatment for Alzheimer’s disease — based on the same relaxed standard used last June to win a highly contested approval for Aduhelm.
The two companies said a “rolling submission” to the Food and Drug Administration for the Alzheimer’s drug called lecanemab has been initiated and will likely be completed in the next several months.
The application will request accelerated approval for lecanemab, also known as BAN2401, based on its ability to reduce levels of toxic amyloid plaques in the brain, and not its effect on slowing the cognitive decline that marks Alzheimer’s.
About the Author Reprints
Create a display name to comment
This name will appear with your comment
