An advisory committee to the U.S. Food and Drug Administration has recommended that the federal agency approve the Alzheimer’s drug donanelumab.
Andrew Harnick/AP
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Andrew Harnick/AP
Advisors to the U.S. Food and Drug Administration have unanimously recommended that the agency approve the Alzheimer’s drug donanelumab.
At a meeting on Monday, the Advisory Committee on Drugs of the Peripheral and Central Nervous System voted 11-0 that donanelumab is effective in slowing the early stages of Alzheimer’s disease and that the drug’s benefits outweigh its risks.
All 11 committee members also suggested that doctors and patients could choose to stop the monthly infusions if tests show most of the amyloid plaques, a hallmark of Alzheimer’s disease, have been removed from the brain.
That means most patients can stop using Eli Lilly’s drug within a year, studies have shown.
Dean Follmann, a statistician and member of the National Institutes of Health committee, said the evidence that donatumumab is effective is “very strong.” While it doesn’t stop the disease, it slows its progression enough to be “meaningful to patients.”
If the FDA follows the committee’s recommendation, donanemab would join a similar drug, marketed under the brand name Leqembi, that was approved by the FDA in 2023.
During the day-long discussion, committee members noted that if approved, donanemab would have some clear advantages over Leqembi. The older drug is given every two weeks indefinitely, while the newer drug is given once a month, and some patients may stop using it.
Leqembi is produced by Eisai in partnership with Biogen and costs more than $26,000 a year. Eli Lilly has not yet announced a price for donanezumab.
Donanemab targets the amyloid plaques that form in the brains of Alzheimer’s patients, and the drug’s approval process has taken an unusually long time.
Eli Lilly applied for “accelerated approval” from the FDA 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 several deaths.
After initially being rejected by the FDA, Eli Lilly applied for traditional approval in mid-2023, with a decision typically made by the end of the 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.
Director of the Alzheimer’s Disease Research and Treatment Center at Brigham and Women’s Hospital in Boston, former director of the Alzheimer’s Disease Research and Treatment Center, and consultant to several pharmaceutical companies.
“Donanemab has been very, very helpful to me,” said Myra Garcia, a 65-year-old Alzheimer’s patient who lives in Upland, California. “I’ve been doing clinical trials for about 2 to 3 years, and I can tell you, I haven’t had any problems.”
The committee discussed the risks associated with donanumab in detail.
Members are particularly concerned about people who carry two copies of the APOE4 gene. The gene greatly increased their risk of developing Alzheimer’s disease, but also greatly increased their risk of bleeding or swelling in the brain when they received donanelumab.
But Colette Johnston, a patient representative on the committee, said even higher-risk patients should have access to the drug.
“Yes, there are risks,” she said. “But when you’re diagnosed with Alzheimer’s, you have nothing but risk.”
Sperling agrees.
“We have to take Alzheimer’s seriously,” she said. “And severe disease requires aggressive treatment.”
The committee recommends that if donanumab is approved, educational materials that clearly explain the drug’s risks should be provided to doctors and patients.
Members also said researchers need to know more about the long-term consequences of stopping treatment. For example: Will amyloid plaques reappear in a few years?
The FDA is expected to take action based on the committee’s recommendations in the coming months.
