This experimental Alzheimer’s drug could be approved this year

47% of participants showed no cognitive decline

A drug that slows Alzheimer’s

American pharmaceutical company Eli Lilly claims their experimental Alzheimer’s drug, called Donanemab, slows worsening of the mind-robbing disease, several media reported.

An 18-month trial

In an 18-month trial, more than 1,700 people in the early stages of Alzheimer's received infusions of Donanemab once a month, Lilly said in a press release.

47% of participants showed no cognitive decline

Almost half of the participants taking the drug, 47%, showed no decline on a key measure of cognition over the course of a year, compared with 29% of people taking a placebo, the pharmaceutical added.

Photo: Ravi Patel/Unsplash

Filing for FDA approval in June

Based on the aforementioned results, the pharmaceutical said it plans to file for approval from the US Food and Drug Administration (FDA) by the end of June.

The medicine removes plaque buildups

Donanemab works by removing plaque buildups in the brain known as amyloid: a hallmark of Alzheimer’s disease, Eli Lilly explained.

Three participants died of side effects

However, Donanemab doesn’t come without risk. In the study, three participants died because of brain side effects.

Adverse effects in the brain

The deaths were attributed to adverse events such as brain swelling or microhemorrhages, known as amyloid-related imaging abnormalities.

Potential risks and potential benefits

“For every medicine, for every disease, there are potential risks and potential benefits,” said Lilly’s chief scientific and medical officer, Dr. Daniel Skovronsky on the press release.

Similar drug already in the market

A similar amyloid-targeting drug, Eisai and Biogen's Leqembi, recently hit the market with similar evidence that it could slow Alzheimer's, but also with the same risks to the brain.

A “never before seen” efficacy

According to Lilly’s chief scientific and medical officer though,

Donanemab’s efficacy “has never been seen before in Alzheimer’s disease.”

Previously rejected by the FDA

However, Lilly had already filed for an approval for Donanemab with the FDA based on earlier results, but was rejected in January as the agency sought more data, CNN reported.

Insurance reimbursement

With the new results, the company will file for full approval, which is expected to lead to broader insurance reimbursement for the medicine, they said.

Potential pricing unknown

However, the company declined to discuss potential pricing for Donanemab before the drug is approved.

Similar drug priced at $26,500 a year

Leqembi, the similar drug that is already in the market, is priced at $26,500 a year and it is not yet covered by Medicare as it was approved on an accelerated basis.

FDA’s full approval

This, however is not expected to be the case with Lilly’s new promising drug Donanemab, as the company wants to file for the FDA’s full approval, which is given once it’s considered safe and effective for most people.

We‘ll have to wait and see

We’ll have to wait and see if the FDA thinks this drug is as effective for Alzheimer’s patients as the pharmaceutical that created it claims it is.