Eli Lilly says FDA delays approval of Alzheimer's drug in surprise move

Eli Lilly says FDA delays approval of Alzheimer's drug in surprise move


Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly & Co.’s shares climbed in early US trading after its experimental drug for Alzheimer’s slowed the progress of the disease in a final-stage trial, paving the way for the company to apply for US approval.

AJ Mast | Bloomberg | Getty Images

Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker’s experimental Alzheimer’s treatment donanemab in a surprise move.

The agency plans to call a last-minute meeting of its outside advisors to further review the treatment’s safety and efficacy in a late-stage trial, Eli Lilly added. The FDA has not disclosed the date of that meeting, so a potential approval would likely come after this month.

The FDA was expected to decide whether to greenlight the medicine by the end of the first quarter. That deadline was already delayed from an expected approval last year. 

The agency’s decision to call for an advisory meeting reflects the high stakes of developing treatments for Alzheimer’s. The condition affects more than six million Americans and currently has no cure, leaving patients who have it with few effective care options. 

It’s another setback for Eli Lilly, which is racing to compete with Biogen and Eisai. Their treatment Leqembi won approval last year, becoming the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. 

Eli Lilly called the delay “unexpected,” but said it is confident in donanemab’s “potential to offer very meaningful benefits to people with early symptomatic Alzheimer’s disease,” according to a release. 

“We will work with the FDA and the stakeholders in the community to make that presentation and answer all questions,” said Anne White, president of neuroscience at Eli Lilly, in a release.



Source

UnitedHealth says it is cooperating with DOJ investigation into Medicare billing practices
Health

UnitedHealth says it is cooperating with DOJ investigation into Medicare billing practices

The UnitedHealth logo on a laptop arranged in New York, US, on Friday, July 7, 2023. Gabby Jones | Bloomberg | Getty Images UnitedHealth Group revealed Thursday it is facing a Justice Department investigation over its Medicare billing practices, adding to a string of setbacks for a company that owns the nation’s largest and most […]

Read More
Healthy Returns: Researchers move closer to a universal cancer vaccine
Health

Healthy Returns: Researchers move closer to a universal cancer vaccine

Wildpixel | Istock | Getty Images A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions. A universal cancer vaccine – what once seemed like a pipe dream – may be inching closer to becoming reality.  On […]

Read More
U.S. to remove mercury preservative from flu shots following RFK Jr. vaccine panel vote 
Health

U.S. to remove mercury preservative from flu shots following RFK Jr. vaccine panel vote 

U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., speaks with Agriculture Secretary Brooke Rollins and Senator Roger Marshall (R-KS) ahead of a roundtable event as part of the “Make America Healthy Again” (MAHA) agenda, on Capitol Hill in Washington, D.C., U.S., July 15, 2025. Ken Cedeno | Reuters The Department of Health […]

Read More