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Alzheimer’s disease medication may come closer to FDA approval



The committee is expected to decide whether to recommend FDA approval of the treatment.

“This is not a meeting to decide whether to approve it or not. This is an advisory committee that will make a recommendation to the FDA and then the FDA will decide if they will approve it,” said Rudolph. Tanzi, a Harvard neurology professor and director of the Aging and Genetics Research Unit at Massachusetts General Hospital, told CNN Wednesday.

“One can expect this advisory committee to have a lot of influence, but once the FDA reviews the advisory committee’s recommendation it may not take any immediate action,” said Tanzi. that is – maybe even until next year.

It is not yet clear from a 343-page meeting document posted online Wednesday whether the commission is inclined towards approval, but several lines of suggestions are in favor of the drug.

The FDA panel reviews drug data

“I don̵
7;t know what’s going to happen on Friday. I don’t know what the FDA is going to decide,” said Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic at Weill Cornell Medicine and New York-Presbyterian in New York. . , who have patients in the initial aducanumab clinical studies.
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“I believe aducanumab may be effective for some patients with the earliest stages of Alzheimer’s, but it’s difficult to predict the opinion of advisory board members,” Isaacson told CNN. on Wednesday.

“Because it’s not just a drug approval ‘Is this effective or is it helpful?’ But is it safe? There are aspects of the cost Will it be cost-effective or be seen as having a clinically significant impact on the patient’s life? Used for someone to get it? “Isaacson said. “So there are many aspects of this meeting and about this approval really needs to be hashed out.

“Is the data perfect and completely accurate? In the opinion of the most rigorous scientists, I cannot say entirely probable,” added Isaacson.

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In March 2019, the aducanumab phase 3 clinical trials were discontinued because of a futile analysis that the trials were incapable of meeting key goals on completion.

But a few months later, Biogen announced that a new analysis, including more patients, showed that aducanumab users had a significant reduction in clinical decline in one trial. Results for several patients in another study also support these findings.

Then in July, Biogen completed its submission to the FDA for a Biological License Application for drug approval. If approved, aducanumab would become the first immunotherapy to reduce the clinical decline of Alzheimer’s disease and also the first to demonstrate that the removal of beta amyloid, a marker of degenerative disorder. brain, for better clinical results.

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The advisory committee meeting document describes the effects of aducanumab in a clinical trial as “powerful and particularly convincing on some of the tools used to evaluate effectiveness,” and also notes about Other negative research.

“There has been no approval of a new drug to treat Alzheimer’s since 2004.” Despite previous failures on other drugs intended to target amyloid beta, the document says. some ways, but there are characteristics of the pharmacological profile of aducanumab and its novel clinical development program design and distinguishing it from earlier agent efforts. “

Experts emphasize that if the drug is approved in the future, it is limited to the treatment of an early stage or mild illness – so it will not benefit all patients – and therapy can be expensive.

‘Whatever the decision is, it’s a watershed moment’

“The best thing to do is to treat amyloid disease before symptoms start or at an early stage,” said Tanzi, one of the scientists who discovered a gene involved in beta-amyloid production in the mid-1980s. of the disease. .

“So that’s the future: early intervention, early detection. Just like cholesterol and heart disease – you don’t wait until someone has congestive heart failure and say, ‘Take Lipitor.’ You get your cholesterol checked from an early age, and if your cholesterol is high, you will try to control it and if necessary, you will take a drug to lower it. In Alzheimer’s disease, beta-amyloid is cholesterol, “Tanzi to speak.

“Another concern is that this is an expensive treatment for the healthcare system,” added Tanzi. “I’m not sure how they will cost, but it could go thousands of dollars a year.”

The Influential Alzheimer’s Association supports the drug’s approval and submitted a letter of support ahead of Friday’s meeting saying “it is necessary to bail out and support the millions of Americans affected every day by The crushing facts of Alzheimer’s disease. “
In a separate statement, the nonprofit Citizen Health Research Group said that the FDA should not approve aducanumab for the treatment of Alzheimer’s due to lack of evidence of its effectiveness.

Michael Carome, the group’s director, said in a written statement on Thursday the drug approval “could do more harm than good.

Opinions differ between clinicians and researchers as to whether aducanumab should be approved.

“A handful of the most respected scientists and researchers in our field have a completely different opinion,” says Isaacson. “Whatever the decision is, it’s a pivotal moment in the area of ​​Alzheimer’s disease.”


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