The advisory committee to the U.S. Food and Drug Administration (FDA) unanimously voted on Monday to recommend the approval of experimental drug donanemab to slow the progression of Alzheimer’s disease.
Data presented at the meeting showed that donanemab did not improve cognition in those who took it, and 7 percent experienced a slight neurocognitive decline after being on the drug for a year and a half. However, brain imaging showed that 76.4 percent of patients achieved clearance of amyloid plaques.
Donanemab breaks down amyloid plaques in Alzheimer’s disease, an incurable neurodegenerative disease characterized by amyloid and tau protein deposits in the brain that are subsequently linked to neurocognitive decline. The drug is designed to slow the disease or improve cognitive decline in its early stages by breaking down amyloid and tau protein accumulation. Dr.
Nilufer Ertekin-Taner also voted in favor of recommending the drug but suggested more prolonged surveillance, especially for groups underrepresented in clinical trial data, such as African Americans, Latin Americans, and those with specific genetic variants that predispose them to a greater risk of Alzheimer’s. Lilly’s clinical trial for donanemab initially tested whether the drug improved cognition and memory. However, the endpoint was changed during the study to evaluate instead whether the drug reduced amyloid plaque.
Due to this change, donanemab’s metric for efficacy was also changed. At first, Lilly u.