FDA Panel Endorses Alzheimer’s Treatment with Potential Disease-Slowing Effects
Federal health advisers endorsed a highly anticipated Alzheimer’s drug from Eli Lilly, paving the way for its anticipated approval for individuals experiencing mild dementia due to the neurodegenerative disease.
The panel of Food and Drug Administration (FDA) advisers unanimously voted in favor of the drug, known as donanemab, acknowledging that its ability to slow down the progression of Alzheimer’s outweighs its associated risks, which include side effects like brain swelling and bleeding, necessitating careful monitoring.
Dean Follmann, a statistician from the National Institutes of Health and a panel member, expressed confidence in the drug’s efficacy based on the evidence presented during the trial.
The final decision on the drug’s approval rests with the FDA, expected later this year. If approved, donanemab would become only the second Alzheimer’s treatment in the U.S. shown to significantly slow cognitive decline and memory loss associated with the disease, following the approval of a similar drug, Leqembi, by Japanese pharmaceutical company Eisai last year.
While the extent of cognitive improvement seen with both drugs amounts to several months, there is debate among experts about whether patients or their caregivers will perceive the difference.
However, Lilly’s approach to studying donanemab, particularly its method of categorizing patients based on levels of a brain protein called tau, raised questions among FDA reviewers. The company’s study suggested that most patients could benefit from the drug without the need for tau imaging.
Despite some uncertainties, many panelists expressed optimism about the potential benefits of donanemab, particularly its proposed advantage of discontinuing treatment in patients with low levels of amyloid, another hallmark protein in Alzheimer’s. However, questions remain about the optimal timing for cessation of treatment and the potential need for patients to resume treatment.
The primary safety concern associated with donanemab was brain swelling and bleeding, although most cases identified during Lilly’s trial were mild. FDA advisers agreed that these risks could be managed through warning labels, physician education, and medical scans to identify patients at higher risk of stroke.
