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.
advertisement
“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
Monthly
$39
Totals $468 per year
$39/month Get StartedTotals $468 per year
Starter
$30
for 3 months, then $39/month
$30 for 3 months Get StartedThen $39/month
Annual
$399
Save 15%
$399/year Get StartedSave 15%
11+ Users
Custom
Savings start at 25%!
Request A Quote Request A QuoteSavings 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
Previous article：
Intellia plays down concerns on accidental germline transmission
Next article： Wildfire smoke exposes gaps in outdoor worker protections
Next article： Wildfire smoke exposes gaps in outdoor worker protections
