FDA advisers unanimously recommend approval of Eli Lilly’s Alzheimer’s disease treatment

Advisers to the Food and Drug Administration voted 11-0 on Monday to recommend the approval of a drug for early Alzheimer’s disease made by Eli Lilly — ruling that the treatment’s ability to slow the cognitive decline in patients outweighed its safety risks.

The unanimous outcome of the daylong advisory panel was the best-case scenario for Lilly, making it likely that the FDA will approve the drug, called donanemab, for a broad population of people diagnosed with mild cognitive impairment due to Alzheimer’s. A decision is expected later this year.

“The benefits outweigh the risks, as long as the risks are being monitored,” said Kathleen Poston, a neurologist at Stanford University and a member of the advisory panel.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.

Already have an account? Log in

Already have an account? Log in

Individual plans

Group plans

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe

Log In