FDA panel endorses approval of Alzheimer’s drug shown to slow progression of disease

A panel of independent advisors to the U.S. Food and Drug Administration has recommended an experimental Alzheimer’s medication that has been shown to significantly slow the progression of mental decline in people with early symptomatic Alzheimer’s disease.

If approved by the FDA, Eli Lilly’s Alzheimer’s drug donanemab would become the second Alzheimer’s drug of its kind currently on the U.S. market that appears to retard the progression of the mind-wasting disease that 6 million Americans suffer from.

The other treatment on the market aimed at slowing Alzheimer’s is Leqembi from Biogen and Eisai.

The FDA typically follows the recommendations of its advisory panels but is not required to do so. The drug is likely to receive full approval in the U.S. later this year.

The 11 committee members unanimously said available data on the drug shows that it is effective at treating Alzheimer’s patients who are in the early stages of the disease.

According to The New York Times, some advisors noted that more data is needed on donanemab in Black and Hispanic patients, among other groups.

“There’s a huge unmet medical need here that hopefully can be addressed,” temporary committee member Sarah Dolan said during a meeting on Monday. Dolan is a consultant for the non-profit organization Critical Path Institute which aims to improve the drug development process.

Clinical trials of the drug donanemab showed that cognitive and functional decline was slowed by more than a third, the company said last year.

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.

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,” Daniel Skovronsky, Lilly’s chief scientific and medical officer, said in May 2023.

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 2023. 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.

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.

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