STAT+: Biogen, Eisai seek fast approval for second Alzheimer’s drug, relying on relaxed FDA standard
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.
