European committee says Lilly Alzheimer’s drug shouldn’t get marketing approval
Advertisement
Read this article for free:
or
Already have an account? Log in here »
To continue reading, please subscribe:
Monthly Digital Subscription
$1 per week for 24 weeks*
- Enjoy unlimited reading on winnipegfreepress.com
- Read the E-Edition, our digital replica newspaper
- Access News Break, our award-winning app
- Play interactive puzzles
*Billed as $4.00 plus GST every four weeks. After 24 weeks, price increases to the regular rate of $19.95 plus GST every four weeks. Offer available to new and qualified returning subscribers only. Cancel any time.
Monthly Digital Subscription
$4.99/week*
- Enjoy unlimited reading on winnipegfreepress.com
- Read the E-Edition, our digital replica newspaper
- Access News Break, our award-winning app
- Play interactive puzzles
*Billed as $19.95 plus GST every four weeks. Cancel any time.
To continue reading, please subscribe:
Add Free Press access to your Brandon Sun subscription for only an additional
$1 for the first 4 weeks*
*Your next subscription payment will increase by $1.00 and you will be charged $16.99 plus GST for four weeks. After four weeks, your payment will increase to $23.99 plus GST every four weeks.
Read unlimited articles for free today:
or
Already have an account? Log in here »
Hey there, time traveller!
This article was published 28/03/2025 (364 days ago), so information in it may no longer be current.
A European regulatory committee rejected Eli Lilly’s U.S.-approved Alzheimer’s disease treatment over potentially dangerous risks of brain bleeding and swelling.
The European Medicines Agency committee said the benefits of the new drug, Kisunla, did not outweigh the risks, and it recommended refusing marketing authorization for it.
The agency’s Committee for Medicinal Products for Human Use said Lilly can ask for a re-examination of its opinion.
Lilly said Friday that it hopes discussions about the drug continue with the agency through re-examination. The Indianapolis drugmaker noted that Kisunla has already been approved in Japan and China, among other markets.
U.S. regulators approved Kisunla last July for mild or early cases of dementia caused by the fatal, mind-robbing disease. That came a year after they approved a similar drug, Leqembi, from Japanese drugmaker Eisai.
The drugs are the first to show a delay in cognitive decline in patients, but it amounts to a matter of months.
The European committee also said last summer that Leqembi should not receive marketing authorization due to some of the same concerns. But it reversed its decision a few months later.
Both Kisunla and Leqembi are laboratory-made antibodies, administered by IV, that target one contributor to Alzheimer’s — sticky amyloid plaque buildup in the brain. Questions remain about which patients should get the drugs and how long they might benefit.
Shares of Eli Lilly and Co. climbed more than $2 to $823.99 Friday morning.