A new study reports Eli Lilly’s Alzheimer’s drug slowed cognitive and functional decline for people with early stages of the disease.
The data, published Monday in the Journal of the American Medical Association, found the experimental drug donanemab slowed decline by 35% compared to a placebo group based on a measure of daily activities such as driving, managing finances and talking about current events. Researchers also shared the data at the Alzheimer’s Association International Conference, in Amsterdam, Netherlands.
Lilly said it submitted an application for traditional Food and Drug Administration approval earlier this year and expected the agency will act before the end of the year.
More than 6 million Americans live with Alzheimer’s disease, the fifth-leading cause of death for adults over 65.
The study brings “hope to people with Alzheimer’s disease who urgently need new treatment options,” Anne White, executive vice president of Eli Lilly and president of Lilly Neuroscience, said in a statement. “If approved, we believedonanemab can provide clinically meaningful benefits for people with this disease and the possibility of completing their course of treatment as early as 6 months once their amyloid plaque is cleared.”
Drugs that target and clear amyloid from the brain have side effects such as brain swelling and tiny bleeds that can be detected via MRI. Nearly 37% of people on donanemab had these side effects, called amyloid-related imaging abnormalities, compared to nearly 15% who received a placebo, the study said.
Most people didn’t notice symptoms. Three people on donanemab died.
Earlier this month, FDA approved Eisai and Biogen’s drug Leqembi but required the drug include a boxed warning about the drug’s known side effects, which include brain swelling and tiny bleeds. Leqembi was the first amyloid-targeting drug to gain traditional FDA approval. Medicare said it will cover Leqembi and other anti-amyloid drugs that gain traditional FDA approval as long as prescribing doctors participate in a registry, or a database that tracks how well the drug works.
