FDA approves Eli Lilly’s early Alzheimer’s treatment

Eli Lilly’s early Alzheimer’s treatment was approved by the Food and Drug Administration on Tuesday, making it the second drug on the U.S. market aimed at slowing progression of the debilitating neurological disease.

The treatment, whose scientific name is donanemab and will be sold under the brand name Kisunla, will compete with Eisai and Biogen’s Leqembi, which got full approval last year. Both therapies are monoclonal antibodies designed to clear amyloid in the brain.

The clearance of Kisunla comes after several regulatory hurdles. The drug was originally expected to be approved earlier this year, but the FDA convened a panel of advisers to weigh the risks and benefits of the treatment. The committee unanimously backed the treatment in a meeting last month.

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