This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Lucy Chard
17 Jun 2024

Alzheimer's drug from Eli Lilly gets recommendation from FDA advisory panel

An advisory panel to the FDA recently analysed the trial for donanemab, the experimental Alzheimer's drug from Eli Lilly, to determine whether they deemed it safe enough to use in patients, even amid concerns over some of the adverse effects seen with the drug. 

The advisors, who are independent of the FDA, were required to vote on whether the experimental treatment’s benefit to patients supersede the risks. The results were unanimous in favour of the treatment. 

The advisory panel were asked to consider the design and results of the clinical trial of the drug. It was pointed out that the trial outline was significantly different to the trial for similar neurodegeneration therapeutic Leqembi, from Eisai and Biogen, which has already successfully been granted approval from the FDA are going through a similar process. 

Both therapies focus on the removal of beta amyloid plaques from the brains of people who are in the early stages of Alzheimer’s disease, and the results of these have both been positive, showing the slowing in disease progression and decline in patients. 

In the trial donanemab is administered via infusion, once every month. 

Prior to the start of the donanemab trial, the levels of the tau protein, which is associated with brain cell death, were measured with the aim of identifying patients that would be more likely to demonstrate a difference over the course of the 76 weeks of the trial. This led to the exclusion of patients with low or no tau protein levels. The advisory panel indicated that this data could suggest the treatment is beneficial, but that testing for tau levels should not be a requirement before treatment is started as this could limit the access to patients. 

"We really are pleased that the advisory committee recognised donanemab's strong positive benefit risk," stated Dawn Brooks, Lilly's development leader for donanemab, after the vote.

The patients experienced slowed progression in memory and thinking problems, by 29% over the course of the trial. In terms of safety, there are a number of concerns specifically around swelling and bleeding in the brain, which commonly coincides with the application of this class of drugs. Swelling occurred in 24% of patients and bleeding the brain 31%, and three patients in the trial died. 

However, the trial design from Lilly was made to reduce risks as much as possible, where regularly brain imaging was conducted, and the patients were able to stop treatment as soon as the amyloid plaques were seen to be cleared, limiting any unnecessary risks for the patients. 

Committee recommendation doesn’t necessarily guarantee approval from the FDA, but in most cases the FDA have been known to follow to the advisory board, suggesting a positive outcome for Lilly’s Alzheimer’s drug. 


Reuters. Lilly Alzheimer's drug gets unanimous backing from FDA advisory panel. [Date accessed 14/06/2024] 

Lucy Chard
Digital Editor - Pharma

Related News