FDA Advisers endorse Early-Stage Alzheimer’s Drug, Donanemab

The FDA has voted to endorse donanemab (Eli Lilly and Company), a monoclonal antibody that is designed to slow the development of early-stage Alzheimer disease. 

If donanemab is approved by the FDA, it would mark the second disease-modifying drug to be granted full approval for Alzheimer.

Data from the Alzheimer’s Association show that 1 in 3 older individuals residing in the US die due to Alzheimer’s disease or a different form of dementia. The mortality rate of the disease is reported to kill more individuals than both prostate and breast cancer 

Although there is no cure to prevent the expansion of Alzheimer disease, donanemab could aid treatment options because its role is to enter the brain and bind to amyloid plaque, enabling the immune system to remove the plaque. 

Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, said in a news release, "We are confident in donanemab's potential to offer very meaningful benefits to people with early symptomatic Alzheimer's disease. It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the results and put donanemab's strong efficacy in the context of safety..."

The findings from the study suggest that donanemab is able to significantly slow clinical progression of Alzheimer disease and amyloid and tau pathology at 76 weeks of treatment.

If approved by the FDA, donanemab would be the second drug on the market to help people in the early stages of Alzheimer’s live a better quality of life for a longer period of time, while providing patients and their doctors with another option for their treatment plans.