FDA Advisory Committee Recommends Approval of New Alzheimer’s Drug

Today, the Food and Drug Administration’s (FDA) eleven-person advisory committee unanimously voted, (11-0) that Eli Lilly’s anti-amyloid Alzheimer’s drug donanemab was effective, and that the benefits of the drug outweigh the risks for people with the earliest stages of Alzheimer’s disease.

The agency is expected to make their final decision on approving the drug in the next few weeks. 

While the drug, which will be given a brand name when it his the market, did not stop the progression of the disease, in the trial, it slowed the progression of Alzheimer’s disease by a small amount.

The study split patients based on the amount of tau tangles in their brain. They measured this protein biomarker using a tau PET scan. Patients with low to medium levels of tau showed more slowing of symptoms than those with high levels of tau. 

Tau PET scans are expensive procedures that are not covered by Medicare, but the advisory committee’s members said they did not think it would be necessary for patients to receive a tau PET scan in order to determine their eligibility for donanemab.

Despite the positive results, committee members raised concerns about the low number of non-white patients in the trial. There is still uncertainty over when clinicians should test to see whether amyloid has been cleared for the brain, and uncertainty over whether patients might need to go back onto treatment after a while. They also emphasized the need for collecting more data.

Sneak Peek of Trial Data for Alzheimer’s Drug Donanemab

Alzheimer’s patients in areas of the U.S. with the highest rates of the disease have limited access to infusion centers that offer Leqembi. Time will tell whether patients prescribed donanemab will face similar access hurdles.