Published 1 year ago

Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug

Summary by Ground News

The FDA has granted accelerated approval to two Alzheimer's drugs so far. Eli Lilly's amyloid plaque-busting therapy won't become the third. FDA cited the submission's lack of data from patients who have been treated with the drug, donanemab, for at least 12 months.

0 Articles

All

Left

Center

Right

Reuters

Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug

Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year.

1 year ago·United Kingdom

Read Full Article

The Globe & Mail

Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer’s drug

U.S. FDA rejects accelerated approval for Alzheimer’s drug, but Eli Lilly expects traditional approval later this year

1 year ago·Canada

Read Full Article

The Detroit News

FDA declines to give accelerated approval to Lilly's Alzheimer's drug, firm says

The company said it received a "complete response letter" from the FDA, which outlines the agency's reasons for declining to approve the drug application in its current form.

1 year ago·Detroit, United States

Read Full Article

Medical Dialogues

USFDA rejects accelerated approval for Eli Lilly Alzheimer's drug Donanemab

"I don't think it says anything negative about the drug. It was just a manifestation of the study design," said Dr. Ronald Petersen, an Alzheimer's expert at the Mayo Clinic in Rochester, Minnesota.

1 year ago·New Delhi, India

Read Full Article

STAT

FDA rejects Lilly’s bid for accelerated approval for its Alzheimer’s drug

The drugmaker said the readout from a Phase 3 study is on track, and if positive, will form the basis of an application for full approval.

1 year ago·Boston, United States

Read Full Article

MedCity News

FDA Rejects Eli Lilly Alzheimer’s Drug, Asks for More Data From Ongoing Study

Eli Lilly’s accelerated approval application for its Alzheimer’s disease drug has fallen short. The company said the FDA is asking for data from more patients—results that must come from a larger study that’s underway but won’t report data until later this year.

1 year ago

Read Full Article

Think freely.Subscribe and get full access to Ground NewsSubscriptions start at $9.99/year

Ground News Article Assistant

Not enough coverage to generate an Article Assistant.