FILE - This April 26, 2017, file photo shows the Eli Lilly & Co. corporate headquarters in Indianapolis. Eli Lilly shares slipped Friday, Jan. 20, 2023, after regulators said they need to see more data on the company’s application for a quick approval of its potential Alzheimer’s disease treatment. (AP Photo/Darron Cummings, File)
FILE - This April 26, 2017, file photo shows the Eli Lilly & Co. corporate headquarters in Indianapolis. Eli Lilly shares slipped Friday, Jan. 20, 2023, after regulators said they need to see more data on the company’s application for a quick approval of its potential Alzheimer’s disease treatment. (AP Photo/Darron Cummings, File)
DCEli Lilly shares slipped Friday after regulators said they need to see more data on the company’s application for a quick approval of its potential Alzheimer’s disease treatment.
Lilly said the Food and Drug Administration wants information from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. The drugmaker gave the update after markets closed Thursday.
The potential treatment aims to clear a plaque from the brain that is a key hallmark of the mind-robbing disease.
Lilly said it had more than 100 patients in the study used for its accelerated approval application. But many were able to stop taking the drug as early as 6 months into treatment due to the reduction in plaque.
The FDA’s accelerated approval program allows drugs to launch in the U.S. based on promising early results, before they’re a confirmed benefit to patients. The agency granted accelerated approval earlier this month to another Alzheimer’s drug, Leqembi from Japan’s Eisai.
Lilly is still seeking full approval for its drug. The company expects to report early results from a late-stage study in the second quarter.
The drugmaker may have to add data from that research to its application for accelerated approval. A Lilly spokesman said the company is working with the FDA on determining next steps to take.
SVB Securities analyst David Risinger called the accelerated approval delay “immaterial.†He said in a research note that the drug’s sales prospects depend more on the late-stage study the drugmaker is wrapping up.
Shares of Indianapolis-based Eli Lilly and Co. slipped more than $4, or about 1%, to $346 Friday morning. Broader indexes climbed slightly.
The ´ºÉ«Ö±²¥ Press. All rights reserved.
Get the latest from ´ºÉ«Ö±²¥News in your inbox. Select the emails you're interested in below.
Automakers are betting big on in-car subscriptions, but have had some trouble conv…
Hudson's Bay has reached deals to sell the leases of six store locations as legal …
Sorry, an error occurred.
Already Subscribed!
Cancel anytime
Thank you .
Your account has been registered, and you are now logged in.
Check your email for details.
Submitting this form below will send a message to your email with a link to change your password.
An email message containing instructions on how to reset your password has been sent to the email address listed on your account.
No promotional rates found.
Secure & Encrypted
Thank you.
Your gift purchase was successful! Your purchase was successful, and you are now logged in.
| Rate: | |
| Begins: | |
| Transaction ID: |
A receipt was sent to your email.
