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New Alzheimer’s treatment drug gets support from FDA advisory panel

Posted at 5:05 PM, Jun 10, 2024

(WXYZ) — A new drug to treat Alzheimer’s disease got the thumbs up from an advisory panel to the U.S. Food and Drug Administration.

If approved by the FDA, it would become the second Alzheimer’s drug on the market.

Alzheimer’s is an incurable disease that affects nearly 7 million Americans today. So, any treatment that can slow down its progression is exciting news.

An outside panel of advisors to the FDA met on Monday to talk about the safety and effectiveness of Eli Lilly’s experimental Alzheimer’s drug called Donanemab. They heard presentations from company representatives as well as FDA members.

The panel agreed that the data shows the drug is effective and its benefits outweigh the risks. The antibody treatment involves an intravenous infusion once a month. It removes toxic plaques from the brain of patients with early Alzheimer’s disease. Experts believe the buildup of these starchlike proteins plays a key role in developing Alzheimer’s.

During Eli Lilly’s clinical trial, the drug slowed the progression of Alzheimer’s by 29% compared to a placebo. However, there was a risk of some potentially serious side effects including brain swelling and bleeding. Three people in the trial died from complications linked to the treatment.

The FDA had originally planned to rule on the drug earlier this year but decided to let the independent advisory panel weigh in first. The agency does not have to follow the recommendations of the advisory group, but in most cases it does.

The FDA went through a similar process before giving the go-ahead to the first fully authorized Alzheimer’s drug last year, called Leqembi.

There are still a lot of questions about where we go from here. We don’t know yet when the FDA will make its final decision on Donanemab. And if the drug is approved, we don’t know how long it will take Eli Lilly to roll it out.

However, it is likely the FDA will require strong warnings on the box about the potentially dangerous risks associated with this class of drug. The agency could also recommend that users get regular MRI scans to check their brain health.

It’s unclear what causes Alzheimer’s disease. The National Institute on Aging says it likely results from age-related changes in the brain combined with genetic, environmental or lifestyle factors. This leads to a decline in cognition, memory and language.

It’s important to note that these new antibody treatments won’t cure Alzheimer’s, but it can give people in the early stages more time to be independent and take part in activities they enjoy.