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FDA Advances Potentially Revolutionary Alzheimer’s Treatment

Posted on Friday, June 21, 2024
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by Andrew Shirley
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Pharmaceutical giant Eli Lilly just cleared one of the final hurdles for approval of a new “early-stage” Alzheimer’s treatment called donanemab. Should the drug receive the final green light, it would be only the second FDA-approved drug for treatment of Alzheimer’s.

Alzheimer’s currently affects more than six million Americans, the vast majority of whom are aged 65 and older. There is no known cure, and no approved treatments are currently available to slow memory loss or reverse the effects of the disease. Alzheimer’s causes the brain to shrink and is the most common cause of dementia, which leads to significant psychological distress in its victims before they pass. Early symptoms include forgetfulness, losing one’s place in a conversation, and a loss of the ability to perform common tasks.

However, donanemab has provided fresh hope for those suffering from Alzheimer’s and those who will develop it in the future. The drug, which is administered intravenously once a week, could hit the market within the next year.

Eli Lilly expected donanemab to be approved earlier this year. However, the FDA’s decision in March to have the drug undergo scrutiny by an independent advisory committee came as a surprise. But Dr. Daniel Skovronsky, chief scientific officer at Lilly, expressed satisfaction with the committee’s unanimous vote, viewing it as a validation of his 25-year effort to treat Alzheimer’s.

The FDA will now complete its review of trial data and make a final decision on approval.

The drug is based on a new theory about how Alzheimer’s develops and spreads through the human brain. The theory, which is gaining traction among medical researchers, posits that Alzheimer’s begins when rough, hard plaques of a protein called amyloid pile up in the brain. These amyloid plaques then ultimately lead to the death of neurons.

Donanemab works by attacking amyloid plaques in patients with early-stage Alzheimer’s. According to a press release from Eli Lilly, in Phase III trials of the drug last year, “Among all participants, treatment with donanemab reduced amyloid plaque on average by 84 percent at 18 months, compared with a 1 percent decrease for participants on placebo.”

Importantly, as Eli Lilly also relayed, “Participants were able to stop taking donanemab once they achieved pre-defined criteria of amyloid plaque clearance.” While many treatments for various diseases on the market today require patients to continue a drug regimen indefinitely, patients prescribed donanemab can come off it as soon as their amyloid plaque build-ups are eliminated. In the Eli Lilly study, “Approximately half of participants met this threshold at 12 months and approximately seven of every ten participants reached it at 18 months.”

Those results seem to represent an astonishing breakthrough in treatment of Alzheimer’s. While the drug hasn’t shown evidence of outright curing the disease, it does appear to dramatically slow the progression of Alzheimer’s symptoms. As The New York Times has reported, in a 76-week-long study of 1,736 patients with Alzheimer’s, “cognitive decline slowed by about 4.5 to 7.5 months in those taking donanemab compared with those who got the placebo.” Meanwhile, nearly half who took donanemab remained at the same cognitive level one year later, compared with 29 percent who got the placebo.

On average, patients with Alzheimer’s live four to eight years after their diagnosis. This new treatment could significantly extend that timeline and give patients with the disease a much higher quality of life.

Donanemab is unique in its use of monoclonal antibody technology. Monoclonal antibodies are specially crafted proteins made in labs to act like the body’s natural defense system, targeting specific harmful substances. They are designed to latch onto specific molecules, such as those found on viruses or cancer cells, marking them for destruction or directly neutralizing them.

In diseases like Alzheimer’s, these antibodies can attach to and help remove harmful proteins like amyloid that build up in the brain, potentially slowing the disease’s progress. Essentially, monoclonal antibodies are like precision-guided missiles that seek out the substances that doctors believe cause Alzheimer’s.

However, like all drugs, donanemab does come with some concerns, as the FDA panel noted. In trials, three patients on donanemab died from “brain swelling or bleeding.” Upon review, the three deaths were attributed to other factors, but the panel nonetheless noted the risk.

Dean Follmann, a member of the FDA panel and statistician at the National Institutes of Health, told NPR that the evidence that donanemab works is “very strong.” Though it won’t cure Alzheimer’s, Follmann said, it will slow progression of the disease enough to be “meaningful to patients.”

If donanemab proves successful, it might also lead to more breakthroughs using monoclonal antibodies. It may well be that someday soon, this debilitating disease which afflicts nearly one in nine seniors could have a permanent cure.

Andrew Shirley is a veteran speechwriter and AMAC Newsline columnist. His commentary can be found on X at @AA_Shirley.

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Patriot Bill
Patriot Bill
22 days ago

If you trust the FDA and CDC, I have this wonderful bridge for sale really cheap

PapaYEC
PapaYEC
22 days ago

NO THANKS!

Laura Bentz
Laura Bentz
22 days ago

This is not a cure, nor does it address the root problem which is gut health. It makes take several more generations to realize none of these monoclonal antibody treatments really help that much to cure the condition. The best bet is to take probiotics early on before the other symptoms develop… And take the proper supplements and vitamins. Sadly, this is just more money for the drug companies…

Misty
Misty
22 days ago

Note to Fauci: This is what gain of function research should be.

John Glose
John Glose
16 days ago

This is good news. Watching somebody suffer with Alzheimer’s is awful. Hope it turns out good!!!!!

Jill Williams
Jill Williams
19 days ago

Please approve this drug as soon as possible. I’ve already lost my mother and two Aunt’s to this horrible disease. Now my husband and father n law have it. I’ve had emergency brain surgery to remove a very large undiagnosed tumor. I constantly worry about getting the disease. My father n law took all the vitamins and proʻbiotics his whole life and they didn’t stop the Alzheimer’s from destroying his life.

Robert Zuccaro
Robert Zuccaro
22 days ago

Right on time for the debates, Joe! Git some…

Kim
Kim
22 days ago

The numbers look pretty good. If the condition can be prevented or delayed with much better diet, exercise, and mental stimulation, I’ll do that first. A couple of my friends had spouses who suffered with dementia for over a decade before they passed away. If it happens to me and the drug doesn’t work, “I’ll move to Oregon”.

Stephen Russell
Stephen Russell
22 days ago

Now lets tackle: Chemo & Kidney Dilaysis too Make= to Counter

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