Alzheimer’s disease treatment drug donanemab received the green light from the FDA advisory committee: Photo

An advisory committee to the Food and Drug Administration has recommended that the federal agency approve the Alzheimer’s disease drug donanemab.

Andrew Harnik/AP

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Andrew Harnik/AP

Food and Drug Administration advisers unanimously recommended that the agency approve the drug to treat Alzheimer’s disease donanemab.

At Monday’s meeting, the Central and Peripheral Nervous System Drugs Advisory Committee voted 11-0 that donanemab is effective in slowing Alzheimer’s disease in the early stages of the disease and benefits of the drug outweighs the risks.

All 11 committee members also recommended that doctors and patients have the option to pause monthly infusions if tests show that most of the amyloid plaques – a hallmark of Alzheimer’s disease – have been removed. out of the brain.

Studies show that means most patients can stop taking drugs made by Eli Lilly within a year.

The evidence that donanemab works is “very strong,” it said Dean Follmann, committee member and statistician at the National Institutes of Health. And while it doesn’t stop the disease, it does slow progression enough to be “meaningful for patients.”

If the FDA follows the committee’s recommendation, donanemab would join a similar class of drugs, sold under the brand name Leqembi. approved by the agency in 2023.

During the daylong discussion, committee members noted that, if approved, donanemab would have several clear advantages over Leqembi. The older drug is taken every two weeks indefinitely, while the newer drug is taken monthly and may be stopped in some patients.

Leqembi, produced by Eisai in partnership with Biogen, costs more than $26,000 a year. Eli Lilly has not announced the price of donanemab.

Donanemab, which targets amyloid plaques that build up in the brains of Alzheimer’s patients, has taken an unusually long time to complete the approval process.

Eli Lilly filed an application with the FDA because “accelerated approval” in January 2023, but the agency said it needed more safety data.

Both donanemab and Leqembi can cause swelling and bleeding in the brain. These effects are often asymptomatic but can be severe and have been associated with some deaths.

After an initial rejection from the FDA, Eli Lilly filed for traditional approval in mid-2023, which would typically result in a decision later that year.

Instead, the agency announced in early 2024 that it would convene an advisory committee before making a decision.

At Monday’s meeting, the committee heard from doctors and patients urging them to approve the drug.

“It is important to do whatever we can to impact slow down this terrible, progressive disease that cannot be avoided.” Consulting for several pharmaceutical companies.

“Donanemab has been very, very helpful to me,” said Myra Garcia, 65, an Alzheimer’s patient who lives in Upland, California. “I’ve been in clinical trials for about two to three years and I can tell you that I haven’t had a single problem with it.”

The Committee discussed in detail the risks associated with donanemab.

Members are especially concerned about people who carry two copies of a gene called APOE4. This gene significantly increased the risk of Alzheimer’s disease, but it also significantly increased the risk of brain bleeding or swelling when they took donanemab.

But Colette Johnston, a patient representative on the committee, said even higher-risk patients should be given the drug.

“Yes, there are risks,” she said. “But when you are diagnosed with Alzheimer’s, you have nothing but risk.”

Sperling echoed that idea.

“We have to take Alzheimer’s seriously,” she said. “And serious illnesses require aggressive treatment.”

The committee recommended that if donanemab is approved, physicians and patients should be provided with educational materials that clearly explain the risks of the drug.

Members also said researchers need to learn more about the long-term consequences of stopping treatment. For example: Do amyloid plaques reappear after a few years, and if so, should doctors start patients on donanemab again?

The FDA is expected to act on the committee’s recommendations in the coming months.