A new Alzheimer’s drug from Eli Lilly has received the support of federal health advisers, raising expectations for its approval for those with mild dementia caused by the disease. The drug, donanemab, has shown the ability to slow cognitive decline, although some side effects like brain swelling and bleeding will need to be monitored. The FDA will make the final decision on approval later this year, and if approved, it would only be the second Alzheimer’s drug in the U.S. to convincingly slow memory problems due to the disease.
The results of Lilly’s study for the Alzheimer’s drug mirrored those of a similar drug from Japanese drugmaker Eisai, with both showing modest slowing of cognitive decline in patients with early-stage Alzheimer’s. Lilly’s study involved 1,700 patients who received monthly IV infusions of the drug, showing a 35% slower decline compared to those who received a sham treatment. The unexpected delay in the FDA’s approval process prompted a public review by a panel of neurology experts, who raised questions regarding the screening of patients based on a brain protein called tau.
Although Lilly’s approach to studying its drug raised questions, many panelists believed that nearly all patients could benefit from the drug regardless of their tau levels. One key aspect of Lilly’s study was the exploration of stopping treatment when patients reach low levels of amyloid, a sticky brain plaque associated with Alzheimer’s. Lilly suggested that stopping doses could reduce side effects and costs, but FDA staff highlighted a lack of data supporting the optimal time to stop or restart treatment.
The main safety concern with donanemab was brain swelling and bleeding, common side effects of amyloid-targeting drugs. Most cases in Lilly’s trial were mild, but three deaths were linked to the drug, involving brain swelling or bleeding. The panel of FDA advisers agreed that these risks could be managed with warning labels, education for doctors, and medical scans to identify patients at greater risk of stroke. Despite the potential risks, experts believe that the benefits of the drug in slowing cognitive decline outweigh the side effects.
Overall, Lilly’s Alzheimer’s drug has shown promising results in slowing cognitive decline in patients with mild dementia caused by the disease. The FDA panel’s recommendation for approval sets the stage for the drug to become the second Alzheimer’s treatment in the U.S. shown to convincingly slow memory problems related to the disease. While questions remain about the optimal use of the drug and managing potential risks, the consensus among experts is that donanemab could represent a significant advancement in the treatment of early-stage Alzheimer’s.
