comprehensive
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 InNext article： Medicare details structure of new drug price negotiation program
