FDA Grants First Full Approval For an Alzheimer's Drug In 20 Years 29
An anonymous reader quotes a report from Politico: The FDA on Thursday granted traditional approval to an Alzheimer's drug for the first time in more than two decades. Now, the question becomes how many people will be able to access the drug, which is targeted at patients in the early stages of the debilitating disease. Medicare has said that it will reimburse the drug's costs -- more than $26,000 annually -- only for beneficiaries enrolled in a nationwide registry that tracks patient side effects and outcomes over time. Patient advocacy groups and some clinicians fear this means that few of the hundreds of thousands of Alzheimer's patients eligible for the treatment will be able to access it.
The agency previously granted Leqembi, developed and manufactured by Eisai and Biogen, accelerated approval before evaluating late-stage clinical trial data earlier this year. The drug moderately slowed trial participants' cognitive decline compared to a placebo, according to the data, but had potentially serious side effects, including brain swelling and bleeding. Under accelerated approval, the Centers for Medicare and Medicaid Services said it would cover Leqembi only for those participating in a randomized clinical trial, of which none were enrolling. Medicare's coverage determination was contrary to the Veterans Health Administration, which said it would cover the drug for its beneficiaries without restriction.
Roughly 6.7 million people in the U.S. have Alzheimer's, and there are few treatments for the disease. Aduhelm, a drug from Biogen that received accelerated approval in 2021, works similarly to Leqembi by targeting proteins thought to be one of the causes of the disease. But both drugs have received little uptake due to Medicare coverage restrictions, and patient and caregiver concerns over the evidence of its modest benefits. There are five existing treatments for Alzheimer's that treat some of the disease's symptoms, but do not slow progression of the disease.
The agency previously granted Leqembi, developed and manufactured by Eisai and Biogen, accelerated approval before evaluating late-stage clinical trial data earlier this year. The drug moderately slowed trial participants' cognitive decline compared to a placebo, according to the data, but had potentially serious side effects, including brain swelling and bleeding. Under accelerated approval, the Centers for Medicare and Medicaid Services said it would cover Leqembi only for those participating in a randomized clinical trial, of which none were enrolling. Medicare's coverage determination was contrary to the Veterans Health Administration, which said it would cover the drug for its beneficiaries without restriction.
Roughly 6.7 million people in the U.S. have Alzheimer's, and there are few treatments for the disease. Aduhelm, a drug from Biogen that received accelerated approval in 2021, works similarly to Leqembi by targeting proteins thought to be one of the causes of the disease. But both drugs have received little uptake due to Medicare coverage restrictions, and patient and caregiver concerns over the evidence of its modest benefits. There are five existing treatments for Alzheimer's that treat some of the disease's symptoms, but do not slow progression of the disease.
So what was the drug they approved 20 years ago? (Score:4, Funny)
I don't remember myself.
Re: So what was the drug they approved 20 years ag (Score:3)
This one exciting hack that drug companies don't want you to know! (Nobody clicks anything anymore without a clickbaity title, right?) https://www.ncbi.nlm.nih.gov/p... [nih.gov]
OR (Score:1)
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So by that account people from India would not get Alzheimer's because that's in basically every meal. A quick google shows that's not true: https://www.brookings.edu/arti... [brookings.edu]
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The amount of bioavailable turmeric circumin in Indian food is generally far below therapeutic levels of the herb.
Why Medicare is broke. (Score:2)
So Medicare is going to pay $26,000/yr so the company can test this drug on people.
Re:Why Medicare is broke. (Score:5, Insightful)
Or could it be that Medicare whats data on the true effects of the drug before it decides to continue to spend that kinda money on something that simply isn't working like promised. I'm not saying for sure it is the latter for sure, but there is no reason to go full-bore negative when there very could be a positive outcome of all this.
Re: Why Medicare is broke. (Score:1, Interesting)
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What exactly would the fix for that entail, hmm?
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Medicare is broke because in the U.S.A. we vote for personal freedom over giving up a little freedom for the benefit of the community and anyone that doesn't let me do whatever I want is called a communist by the right or a facist by the left.
Medicare is broke because it's a Ponzi scheme. Its funding depends on a certain level of population growth and a certain number of years of coverage after retirement, but people aren't having as many kids, and they're living longer.
Medical care in general is expensive because the whole liability model is broken, the use of for-profit companies to provide essential services is fundamentally broken, the use of for-profit insurance is fundamentally broken, and on top of that, you have drug companies expecting
Re: Why Medicare is broke. (Score:2)
True life example. I recently got a CPAP machine. The mask I use can be bought online for $80 the EOB from the insurance company says they paid $800.
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True life example. I recently got a CPAP machine. The mask I use can be bought online for $80 the EOB from the insurance company says they paid $800.
They charge $800 because they know they'll only get reimbursed for $80. Drugs are the same way, as is pretty much everything else.
Wow, half of my earlier comment got eaten by Slashdot somehow. What I attempted to say was something along the lines of:
Meanwhile, you have drug companies expecting a huge payout for their drugs, because not enough R&D is being publicly funded. Drug research should be pure research, without a profit motive.
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Medicare works pretty well actually. So naturally republicans want to make massive cuts. https://newrepublic.com/post/1... [newrepublic.com]
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Hospitals that serve majority Medicare and Medicaid patients tend to go bankrupt and close.
What does it actually do? (Score:5, Interesting)
I haven't heard of ANY Alzheimer's drug that has medically useful properties. Most of them just claim to reduce the amount of some protein or other. That's only useful is if actually produced improvement, or at leas slows decline.
AFAIKT, the FDA approval these days means the drug companies/families of patients lobbied for the drug to be approved, and the FDA decided that it wasn't actively too dangerous. Reducing amyloid isn't proven to be that helpful. That's just one theory will a lot of contradicting evidence.
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The problem is that we don't know yet the type of amyloid (or precursors thereof) to target. There's many. We haven't exhausted the number of possibilities. See my previous reply above.
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Amyloid exists in various forms such as soluble and insoluble and different locations. Amyloid formation is basically monomer to dimer to oligomers (of certain sizes) to (misfolding?) pre-protofibrillar to protofibrillar to fibrillar then modified fibrillar. Previously it was thought that targeting it at the insoluble plaque stage was fine, but now with a lot of research and experiments it looks like we have to target it in the soluble form which seems to be toxic. This new drug targets the amyloid at the p
Red flags for me.... (Score:4, Informative)
You got an experimental drug going after amyloid plaques and the amyloid plaque data as a cause of alzheimer's is under significant scrutiny.
https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease
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No, the issue appears to be that determining what stage and type of amyloid to target. Amyloid exists in various forms such as soluble and insoluble and different locations. Amyloid formation is basically monomer to dimer to oligomers (of certain sizes) to (misfolding?) pre-protofibrillar to protofibrillar to fibrillar then modified fibrillar. Previously it was thought that targeting it at the insoluble plaque stage was fine, but now with a lot of research and experiments it looks like we have to target it
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No, the issue appears to be that determining what stage and type of amyloid to target. Amyloid exists in various forms such as soluble and insoluble and different locations. Amyloid formation is basically monomer to dimer to oligomers (of certain sizes) to (misfolding?) pre-protofibrillar to protofibrillar to fibrillar then modified fibrillar. Previously it was thought that targeting it at the insoluble plaque stage was fine, but now with a lot of research and experiments it looks like we have to target it in the soluble form which seems to be toxic. This new drug targets the amyloid at the protofibrillar stage.
My cynical suspicion is that Alzheimer's is caused by in adequate levels of non-misfolded amyloid proteins in the brain, and that the deposits are a symptom of the mis-folding, so reducing the prions will just slow the rate of conversion from usable forms to unusable forms, which will slow the progression, but only a little. If I'm right, then a proper cure likely depends on increasing the amount of amyloid production *and* getting the immune system to *aggressively* attack the prions as soon as they form.
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You realize that's fabrication was only about a SPECIFIC form of amyloid called AB*56 right? How much does that need to be explained? Read your own article.
medicare premiums (Score:3)
This will require medicare premiums to increase. Medicare premiums are what old people pay to be on Medicare. The US is the only country that taxes people only if they are old.
What about Aducanumab's approval? (Score:2)
Or is there some technical distinction without a difference we should be aware of? Who was fired, fined or jailed at FDA for corruptly approving Aducanumab? Oh right absolutely nobody.
Until half of FDA's funding does not come from the drug companies.
Until drug companies are no longer allowed to conduct their own studies of their own products.
While the revolving door continues to be dutifully maintained.
My default position relative to FDA's stamp of approval is to ignore it outright until there is compelli
Will this increase or decrease (Score:2)
...Biden jokes?
Amyloid Cascade Hypothesis Antigen (Score:1)