An experimental treatment from Eli Lilly significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease in a large clinical trial, the company announced Wednesday, giving hope to a new category of Alzheimer’s treatments.
During the 18-month study of nearly 1,700 people, donanemab slowed patients’ rate of memory decline and ability to perform daily activities by 35 percent compared to placebo, the company said, the first ever investigational Alzheimer’s medicine to have such strong results at this point in a clinical trial.
As a result, Lilly said it plans to file for approval with the Food and Drug Administration (FDA) this quarter. The drug will compete with a similar Alzheimer’s treatment from Eisai and Biogen, Leqembi, which won FDA approval in January.
The results show that if approved, donanemab “may represent a significant step forward for people with early symptomatic Alzheimer’s disease, and allow them to continue to participate in activities that are meaningful to them,” said Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience.
The results were announced in a press release and have not yet been peer reviewed.
But the positive outcome could be tempered by two participants who died due to a type of brian swelling or bleeding that is associated with these types of drugs. The death of a third participant is likely also due to the side effect.
Donanemab is a monthly infusion therapy that works by targeting plaque in the brain known as amyloid, which is a known hallmark of Alzheimer’s patients. The study enrolled people with early symptomatic Alzheimer’s disease, which includes mild cognitive impairment and mild dementia.
Patients who took donanemab were 39 percent less likely to progress to the next stage of the disease during the study, and almost half of the participants taking the drug showed no decline on a key measure of cognition over the course of a year, the company said.
More than half of patients completed the treatment in the first year and 72 percent completed it in 18 months due to clearance of brain plaque.
The company and Alzherimer’s advocates indicated they are going to use the results of the trial to press the Centers for Medicare & Medicaid Services to change its policy on covering these experimental Alzheimer’s drugs.
Currently, Medicare will only cover the majority of costs for patients participating in federally approved clinical trials.
“These are the strongest phase 3 data for an Alzheimer’s treatment to date. This further underscores the inflection point we are at for the Alzheimer’s field,” said Maria Carrillo, the Alzheimer’s Association chief scientific officer, in a statement.
“Yet, Medicare stubbornly continues to block access for the people who could benefit,” Carrillo said.
Alzheimer’s affects more than 6 million Americans, with an estimated 1.7 million to 2 million people over 65 in the early stages of the disease, according to Lilly.
“We believe our data meets the ‘high level of evidence’ the Centers for Medicare & Medicaid Services (CMS) has described as the trigger for reconsideration of its National Coverage Determination. People with early Alzheimer’s disease need and deserve full coverage and access for approved therapies,” White said.
The company previously applied for accelerated approval with FDA in January but was denied because the agency wanted to see more data.