Eli Lilly Alzheimer’s drug gets FDA panel date after approval delay

An outside panel of advisers to the Food and Drug Administration (FDA) will meet next month to discuss a new Alzheimer’s drug from Eli Lilly, the company said Tuesday. 

The panel will meet June 10, three months after the FDA said it wanted advisers to scrutinize the safety and effectiveness of the drug, called donanemab.  

Donanemab is a monoclonal antibody that targets a brain plaque called amyloid. It’s intended to treat early-stage disease and is administered every four weeks by intravenous infusion. 

The FDA’s decision came as a surprise to the company; Lilly submitted its traditional approval application of donanemab to the FDA last year and anticipated getting the green light by early 2024.   

The advisory panel meeting was the second major delay to donanemab’s potential approval, after Lilly was declined accelerated approval by the FDA in January 2023. 

More than 6 million people in the United States have been diagnosed with Alzheimer’s, and that number is expected to rise as the population ages. There is no cure, but there are about 1 million people with early-stage disease who could benefit most from the drug.  

Donanemab would be the second successful Alzheimer’s drug on the market after the FDA last year approved Biogen and Eisai’s Leqembi. The late-stage clinical trial data from Lilly was similar to the data cited by the FDA when it approved Leqembi, which is why the company expected an easy approval for the potential competitor. 

According to Lilly, donanemab slowed Alzheimer’s disease progression by 35 percent relative to placebo treatment, in an 18-month clinical trial that enrolled 1,700 patients with early-stage disease. In practical terms, that translated to delaying progression by about four months.  

There were serious risks identified in the trial, raising concerns that the risk outweighed the benefit. Three people died after developing serious brain bleeding or swelling.