An experimental Alzheimer’s medication has been shown to significantly slow the progression of mental decline in people with early symptomatic Alzheimer’s disease, according to its maker, Eli Lilly.
A clinical trial of the drug donanemab showed that cognitive and functional decline was slowed by more than a third, the company said Wednesday.
Donanemab targets a protein called amyloid which forms plaque in the brain. The buildup of plaque is believed to be the catalyst that worsens Alzheimer’s.
Eli Lilly said that based on the results of the phase 3 clinical trial, it will file for approval from the U.S. Food and Drug Administration by the end of June. Approval of the drug could take about 10 months.
The results of the trial were released by the company in a press release and have not been peer-reviewed.
About 47% of the patients who took part in the study had no decline in cognitive function 12 months after the start of treatment with donanemab, according to Lilly. Participants in the study were scored using a clinical-dementia rating system.
About 52% of people who took donanemab completed their treatment within a year, and 72% were able to stop treatment by 18 months as a result of clearance of amyloid plaque in the brain, according to the study.
“These are levels of efficacy that just haven’t been seen before in Alzheimer’s, setting a new benchmark for what’s possible in this disease,” Dr. Daniel Skovronsky, Lilly’s chief scientific and medical officer, said.
Some side effects were recorded with the drug. About 24% of patients taking donanemab had brain swelling and bleeding, Lilly said. About 1.6% of the abnormalities were classified as serious, including two people who died from them and a third person who died after an abnormality, Lilly said.
Lilly filed for accelerated approval for donanemab from the FDA based on earlier results but was rejected in January. The FDA asked for more data before it could make a decision.
While donanemab was shown in the trial to clear amyloid, the therapy doesn’t cure Alzheimer’s.
According to the company, full results of the study will be presented at the Alzheimer’s Association International Conference in July and submitted for publication in a peer-reviewed clinical journal.
The company has not said what the drug may cost.
According to The Wall Street Journal, new Alzheimer’s drugs have faced limited insurance coverage, with Medicare denying routine coverage of anti-amyloid Alzheimer’s drugs.
More than 6 million Americans have Alzheimer’s disease, according to the Alzheimer’s Association, and up to 2 million people over age 65 are likely in the early stages of the disease, according to Lilly.