Eli Lilly’s new Alzheimer’s drug has garnered support from federal health advisers, paving the way for its anticipated approval for treating mild dementia linked to Alzheimer’s disease.
Advisers to the Food and Drug Administration (FDA) unanimously agreed that the benefits of the drug, donanemab, in slowing Alzheimer’s progression outweigh the associated risks, such as brain swelling and bleeding, which require monitoring.
The FDA will decide on the drug’s approval later this year. If approved, donanemab will become the second Alzheimer’s drug in the U.S. shown to effectively slow cognitive decline. Last year, the FDA approved a similar drug, Leqembi, developed by Eisai.
While both drugs only slow the disease by several months, causing debate among experts about their perceptible impact on patients, Lilly’s research approach raised questions. The company grouped patients by their tau protein levels, which predict cognitive impairment severity, leading the FDA to question if tau screening via brain scans would be necessary before treatment. However, most advisers believed the drug could be prescribed without such screening.
Panel chair Dr. Thomas Montine from Stanford University stated that requiring tau imaging would pose practical and access challenges.
Lilly’s results paralleled those of Leqembi, showing modest cognitive slowing in early-stage Alzheimer’s patients. In a 1,700-patient study, monthly IV infusions of donanemab slowed cognitive decline by about 35% compared to a placebo.
Although the FDA had been expected to approve the drug in March, it opted for a public review of Lilly’s data. Unusual study methods, like measuring tau levels and stopping treatment when amyloid plaques were minimal, prompted the review.
Despite these concerns, the possibility of halting treatment to reduce costs and side effects was seen as promising by many panelists. Dr. Tanya Simuni from Northwestern University highlighted the potential cost savings and the need for patient monitoring to determine if and when treatment should resume.
As reported by ETPharma, brain swelling and bleeding were the main safety issues, typical of amyloid-targeting drugs. Most cases in Lilly’s trial were mild, though there were three deaths linked to the drug, all involving brain complications. The panel agreed these risks could be managed with warning labels, doctor education, and medical scans to identify high-risk patients.