FDA advisers back Eli Lilly's Alzheimer's drug donanemab, citing its benefits over risks like brain swelling
Federal health advisers backed Eli Lilly's Alzheimer's drug, donanemab, on Monday, preparing for its expected approval for mild dementia caused by the disease, as reported by The Canadian Press.
Food and Drug Administration (FDA) advisers voted unanimously, agreeing the drug's ability to slow Alzheimer's progression outweighs its risks, including brain swelling and bleeding, which require monitoring.
“I thought the evidence was very strong in the trial showing the effectiveness of the drug,” said panel member Dean Follmann, a National Institutes of Health statistician.
The FDA will decide on approval later this year. If approved, donanemab would be the second US drug proven to slow cognitive decline and memory issues in Alzheimer's patients. The FDA previously approved a similar drug, Leqembi, from Japanese drugmaker Eisai.
Both drugs offer a modest slowdown of several months, leading to debate on whether patients or their loved ones will notice the difference. Lilly’s study grouped patients based on their levels of tau, a brain protein predicting cognitive problem severity.
This raised FDA questions about whether patients would need brain scans for tau before receiving the drug. However, most panelists believed the drug's benefits justified prescribing it without such screening.
“Imposing a requirement for tau imaging is not necessary and would raise serious practical and access concerns to the treatment,” said Thomas Montine of Stanford University, who chaired the panel.
Lilly’s results mirrored those of Leqembi, showing modest slowing of cognitive problems in early-stage Alzheimer’s patients. In a study of 1,700 patients, those receiving monthly IV infusions of donanemab declined about 35 percent more slowly than those receiving a placebo.
The FDA had expected to approve the drug in March but delayed the decision to allow a public review of Lilly’s data. Lilly's approach, including measuring tau levels and excluding patients with low or no tau, led to the meeting. Panelists felt there was enough data to support the drug's benefits for nearly all patients.
Lilly also studied stopping the drug when patients reached very low amyloid levels, a brain plaque contributing to Alzheimer's.
This could reduce side effects and costs. FDA staff noted Lilly provided limited data on the optimal stopping time and the need for restarting treatment. Despite these questions, panelists saw potential in stopping doses.
“It’s a huge cost savings for society. We’re talking about expensive treatment, expensive surveillance,” said Tanya Simuni of Northwestern University. Experts agreed patients should be tracked and tested to determine if and when they need to resume treatment.
Donanemab's main safety issues include brain swelling and bleeding, common in amyloid-targeting drugs. Most cases in Lilly's trial were mild.
The FDA linked three deaths in the donanemab study to the drug, all involving brain swelling or bleeding, with one due to a stroke, a complication more frequent in Alzheimer's patients.
The FDA's panel recommended addressing these risks with warning labels, doctor education, and medical scans to identify high-risk patients.
