US FDA Delays Approval for Experimental Alzheimer’s Drug: What Is Donanemab?

Donanemab slows the progression of Alzheimer’s in patients who are still in the early stages of the disease.

The United States Food and Drug Administration delayed the approval for Eli Lilly’s donanemab, an experimental treatment drug for early Alzheimer’s patients, for the second time, after it rejected an ‘accelerated approval’ request for the drug last year.

Eli Lilly said that the FDA will be discussing the drug’s safety and efficacy with an advisory committee. In a statement, the company said, “It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process.”

It added,

“The date of the advisory committee meeting for donanemab has yet to be set by the FDA, and, as a result, the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024.”

FIT decodes the news for you.

What is donanemab? Donanemab is a drug that is shown to slow the cognitive decline and progression of Alzheimer’s in patients who are still in the early stages of the disease.

In a clinical trial conducted last year, donanemab slowed the progression of memory problems in early Alzheimer’s patients by 22 percent, and that of thinking problems by 29 percent.

The drug breaks down the beta amyloid protein that is present in the brain in Alzheimer’s patients. It is supposed to be given on a monthly basis to patients. 

The drug was also shown to be effective against tau protein, and slowed the progression of Alzheimer’s in patients with tau by 35.1 percent.

Why has the drug approval been delayed? Donanemab has side effects such as bleeding and swelling in the brain. 

Since the patients can stop the treatment once the beta amyloid protein is removed from the brain, Dr Mary Sano, Director, Alzheimer’s Disease Research Center, Mount Sinai, New York, told Reuters that “the FDA may be struggling with how to manage patients who stop the treatment and later need to restart it, which could expose them to additional side effects.”

Another reason for the FDA’s delay in approval could be linked to the fact that three people passed away during the clinical trials of the drug.

The FDA also told Eli Lilly that it wanted to get a better understanding of the clinical trial data and the treatment.

Is this the only drug for Alzheimer’s patients? No, two other drug therapies by Eisai and Biogen have been approved in the past, within two years of each other. One of the approved drugs – aducanumab – has now been discontinued.

The other drug, leqembi, was granted approval by the FDA in July last year.