Art WalaszekJan 6, 2023

FDA approves #lecenemab via accelerated mechanism (same as #aducanumab):

https://www.statnews.com/2023/01/06/fda-approves-alzheimers-drug-leqembi-eisai/

CMS will still need to decide about Medicare coverage.

Eisai expected to seek full FDA approval based on additional cognitive outcomes data.

#dementia #alzheimers

FDA approves Alzheimer's drug shown to moderately slow cognitive decline in early stages of the disease

Eisai's newly approved Alzheimer's drug, Leqembi, has limitations but is groundbreaking in a field that hasn’t seen real medical progress in decades.

STAT