Washington, July 18 – Eli Lilly’s Alzheimer’s drug has shown promise to slow down cognitive and functional decline in people who are in early stages of the disease’s progression, according to results of phase 3 trial.
This comes on the heels of Eisai and Biogen’s lecanemab, known by the brand name Leqembi, becoming the first to get US Food and Drug Administration’s (FDA) full approval, earlier this month, to slow down disease progression in adult patients with Alzheimer’s disease.
Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and eventually, the ability to carry out simple tasks.
The drug, donanemab administered intravenously once a month, works by removing plaque build ups in the brain known as amyloid — a hallmark of the disease.
The trial, lasting for nearly two years involved 1,736 participants with early symptomatic Alzheimer disease.
The company, in a statement, said donanemab slowed the progression of Alzheimer’s by 60 per cent for patients.
In May, Lilly said that donanemab slowed clinical decline by 35 per cent compared to placebo, and resulted in 40 per cent less decline on the ability to perform activities of daily living, said the company announcing phase-3 trial results.
“These results demonstrate that diagnosing and treating people earlier in the course of Alzheimer’s disease may lead to greater clinical benefit,” said Liana Apostolova, professor in Alzheimer’s Disease research and professor in neurology, radiology, medical and molecular genetics at Indiana University School of Medicine.
“The delay of disease progression over the course of the trial is significant and will give people more time to do such things that are meaningful to them.”
The findings, published in JAMA, showed results were less robust for older, later-stage patients as well as those with higher levels of a protein called tau that has been linked to Alzheimer’s disease progression.
Eli Lilly aims to seek full approval from the US FDA for donanemab.
A decision is expected before the end of 2023.
Both Leqembi and donanemab target amyloid beta and are administered intravenously. Leqembi is dosed once every two weeks, while donanemab is dosed once every four weeks.
Halving the number of trips to a hospital or infusion centre with donanemab could be a gamechanger for many patients.
