An advisory committee to the Food and Drug Administration has recommended that the federal agency approve the Alzheimer’s drug donanemab.
Andrew Harnik/AP
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Andrew Harnik/AP
Food and Drug Administration advisers have unanimously recommended that the agency approve the Alzheimer’s drug donanemab.
At a meeting Monday, the Central and Peripheral Nervous System Drugs Advisory Committee voted 11-0 that donanemab is effective in slowing Alzheimer’s in the early stages of the disease and that the drug’s benefits outweigh its risks.
All 11 committee members also recommended that doctors and patients have the option to stop the monthly infusion if tests show that amyloid plaques – the hallmark of Alzheimer’s – have been cleared from the brain.
Studies show that most patients can stop the drug, made by Eli Lilly, within a year.
The evidence that donanemab works is “very strong,” said Dean Follmann, a committee member and statistician at the National Institutes of Health. And even if it doesn’t stop the disease, it slows it down enough to be “meaningful to the patient.”
If the FDA follows the committee’s recommendations, donanemab will join a similar drug, sold under the brand name Leqembi, that the agency approved in 2023.
During the day’s discussion, committee members noted that, if approved, donanemab would have several clear advantages over Leqembi. The older drugs are given every two weeks indefinitely, while the new ones are given monthly and can be discontinued for some patients.
Leqembi, made by Eisai in partnership with Biogen, costs more than $26,000 a year. Eli Lilly has not disclosed the price of donanemab.
Donanemab, which targets the amyloid plaques that build up in the brains of Alzheimer’s patients, has taken too long to work its way through the approval process.
Eli Lilly applied to the FDA for “accelerated approval” in January 2023, but the agency said it needs more safety data.
Donanemab and Leqembi can cause swelling and bleeding in the brain. These effects are usually asymptomatic, but can be serious and have been linked to some deaths.
After initially being rejected by the FDA, Eli Lilly applied for traditional approval in mid-2023, which would normally result in a decision by the end of the year.
However, the agency announced in early 2024 that it would form an advisory committee before making a decision.
At Monday’s meeting, the committee heard from doctors and patients who called for the drug to be approved.
“It is important to do whatever we can to stop this terrible progressive disease,” said Dr. Reisa Sperling, who directs the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital in Boston and has served as a consultant for several drug companies.
“Donanemab has been very, very helpful for me,” said Myra Garcia, 65, an Alzheimer’s patient who lives in Upland, California. “I have been doing clinical trials for about 2 to 3 years, and I can say that I have not had any problems.”
The committee discussed the risks associated with donanemab at length.
Members are particularly concerned about people who carry two copies of a gene called APOE4. The gene increases the risk of developing Alzheimer’s, but also increases the risk of brain bleeding or swelling while receiving donanemab.
But Colette Johnston, the patient representative on the committee, said higher-risk patients should have access to the drug.
“Yes, there are risks,” he said. “But if you get an Alzheimer’s diagnosis, you’re not at risk.
Sperling supported the idea.
“We need to take Alzheimer’s disease seriously,” he said. “And serious illness requires aggressive treatment.”
The committee recommends that if donanemab is approved, doctors and patients should be provided with educational materials that clearly explain the drug’s risks.
Members also said researchers need to learn more about the long-term consequences of stopping treatment. For example: Do amyloid plaques reappear after many years, and if so, should the doctor give the patient donanemab again?
The FDA is expected to act on the committee’s recommendations in the next few months.
