FDA decision on Alzheimer’s drug Donanemab is getting delayed – What it means for patients!

FDA decision on Alzheimer's drug Donanemab is getting delayed
FDA decision on Alzheimer's drug Donanemab is getting delayed. Credit | Stock.Adobe

United States: The FDA of the US has already made it clear by saying that they are going to take more time to make a decision on a promising Alzheimer’s medicine made by the drug’s producer donanemab.

About Eli Lilly’s donanemab drug

Eli Lilly revealed that the FDA was not expected to announce a verdict about a drug known as donanemab, which was specially formulated for older people with Alzheimer’s who were coming up with first signs of the disease until after the first quarter of 2024, whereas there would be the need for the agency to convene an advisory committee in relation to the drug.

The manufacturer commented in the statement that there is not yet a real date when a brain-systems review panel will be prepared by the agency.

The company added that it is unusual for an advisory panel to meet after the regulated agency’s expected decision date, as the panel for donanemab follows the same processes for two other treatments the FDA has approved.

What do the Company officials have to say?

Visual Representation – Eli Lilly Drugs. Credit | Getty images

Anne White, executive vice president of Eli Lilly and Company said, “We are confident in donanemab’s potential to offer very meaningful benefits to people with early symptomatic Alzheimer’s disease,” and, called it, “unexpected” if an advisory committee would be convened “at this stage in the review process,” as USA Today reported.

Know about the study

Visual Representation – Eli Lilly & Co.’s headquarters. Credit | Getty images

A study, published in July by Eli Lilly in the Journal of the American Medical Association, focused on almost 1,700 people aged 60 to 85, who enrolled from 8 countries, with the aim being to distinguish the effects of donanemab on early Alzheimer’s treatment.

The research exhibited the drug has the ability by up to 35 percent to slow down cognitive and functional decline as compared to the placebo group participants.

The difference had been observed on a daily basis according to the degree of activity in which patients were working, for example, driving a car, designing a budget, or discussing the current event.

Effectiveness of the drug

Visual Representation – Alzheimer’s Disease Drugs. Credit | Shutterstock

Alzheimer’s experts continue to believe in the effectiveness of donanemab demonstrated termination of memory and thinking difficulties in people with the initial stage of AD during late-stage clinical trials data have shown, according to Eli Lilly, as USA Today reported.

But as Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation added, “This is not a setback.”

According to him, the FDA is “doing the due diligence” before the applicant for the drug so that patients do not face any risk while using the same.

Donanemab is one of several new drugs which are used in the first stage of Alzheimer’s patients’ treatment. The medication targets amyloid – which is the sticky protein that has been known to form plaques associated with cognitive and memory impairment in the brains of Alzheimer’s patients.

Development of more such drugs

For more than two decades now, drug developments by drug companies have led them to identify these types of plaque and clear them from patients’ brains. Last January 2023, the Food and Drug Administration (FDA) approved the sale of Leqembi by Eisai and Biogen to be used in the early stages of Alzheimer’s disease patients.

In 2021, Biogen’s Aduhelm became the first medicine to receive authorization despite the factual substance of the studies being a subject for scrutiny − subsequently resulting in two House Committees initiating investigations. Biogen eventually discontinued Aduhelm, as USA Today reported.

The Company declared that Donanemab is still part of their research work and they are actively investigating it in additional trials.