Eisai Alzheimer’s Drug Gets FDA Breakthrough Therapy Designation
- Status revs up development, review; no guarantee of approval
- Second drug designed to remove amyloid from the brain
This article is for subscribers only.
Eisai Co. and Biogen Inc. said that the companies’ experimental Alzheimer’s drug lecanemab, now in late stage human trials, has received a breakthrough therapy designation from the U.S. Food and Drug Administration.
Lecanemab, also known as BAN2401, is the second drug the companies are working on that’s designed to remove amyloid from the brains of Alzheimer’s patients in an attempt to slow cognitive decline. The first -- the monoclonal antibody Aduhelm -- was approved by the FDA earlier this month for treating Alzheimer’s in one of the most controversial decisions in recent agency history.