FDA Approves New Treatment for Early Alzheimer's (nytimes.com) 19
The Food and Drug Administration on Friday approved a new Alzheimer's drug that may modestly slow the pace of cognitive decline early in the disease, but also carries risks of swelling and bleeding in the brain. From a report: The approval of the drug, lecanemab, to be marketed as Leqembi, is likely to generate considerable interest from patients and physicians. Studies of the drug -- an intravenous infusion administered every two weeks -- suggest it is more promising than the scant number of other treatments available. Still, several Alzheimer's experts said it was unclear from the medical evidence whether Leqembi could slow cognitive decline enough to be noticeable to patients.
Even a recent report of findings from a large 18-month clinical trial, published in the New England Journal of Medicine and co-written by scientists from the lead company making the drug, concluded that "longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer's disease." Eisai, a Japanese pharmaceutical company, led the development and testing of the drug. It is partnering with the American company Biogen, maker of the controversial Alzheimer's drug Aduhelm, for its commercialization and marketing, and the companies will split the profits equally. Eisai said the list price for Leqembi (pronounced le-KEM-bee) would be $26,500 per year. The price is slightly lower than Aduhelm's, but higher than that recommended by some analysts.
Even a recent report of findings from a large 18-month clinical trial, published in the New England Journal of Medicine and co-written by scientists from the lead company making the drug, concluded that "longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer's disease." Eisai, a Japanese pharmaceutical company, led the development and testing of the drug. It is partnering with the American company Biogen, maker of the controversial Alzheimer's drug Aduhelm, for its commercialization and marketing, and the companies will split the profits equally. Eisai said the list price for Leqembi (pronounced le-KEM-bee) would be $26,500 per year. The price is slightly lower than Aduhelm's, but higher than that recommended by some analysts.
Interesting... (Score:1)
> The Food and Drug Administration on Friday approved a new Alzheimer's drug that may modestly slow the pace of cognitive decline early in the disease, but also carries risks of swelling and bleeding in the brain.
If you mention the risk of swelling of bleeding on social media you get banned for contributing to drug hesitancy. Damn anti-drugorz.
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No one ever got banned on social media for referring to FDA studies on drugs
Making up things and being both dishonest and ignorant of how statistics work though... i wouldn't say people should be banned but definitely mocked, derided and laughed at.
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What did she say in the tweet in reference to the journal becuase there are no "well respected" medical journals that show positive efficacy from Ivermectin. It has been a gigantic, massive goose egg.
I can already picture what was said and what was linked to and I don't think she should have been banned but definitely mocked.
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IIUC, the new treatment also (probably) increases the risk of death. Perhaps that's only if you're on a blood thinner, but Derek Lowe considered the reports as released to be insufficient to make that claim. And the company wasn't even really admitting that.
Father had something... (Score:5, Interesting)
My father had some kind of dementia. It was never identified exactly which one.
Over a period of about 10 years 62-72 he was in slow decline. Got very forgetful, couldn't follow TV shows or movies, had a hard time talking about anything "new". Could talk all day about stuff that happened 20 years ago. Over the last two years of his life (73-74) he had a very rapid decline. To the point of not even being able to carry on any kind of meaningful conversation. I knew things were bad when I would call him and try to talk and he couldn't think of anything to say back to me. Mostly "Huh. OK." or "I don't follow what your saying." type of responses.
It was miserable for him and for the entire family. And with our healthcare system it almost bankrupted him and my mother as they tried to navigate care for him. With some dementia care facilities charging as much as 10K a month and medicare refusing to pay even small portions of said care it was a nightmare.
My father finally passed away and as much as I hate to say it, I wish it had happened sooner. It was a living hell for everyone involved.
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The worst part about this sort of thing is how financially draining it is especially for middle class families. I don't get why dementia care needs to cost $10K a month. Can anyone who has worked at these facilities provide some insight?
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The worst part about this sort of thing is how financially draining it is especially for middle class families.
The worst part is how they lose memory and die. It has nothing to do with middle class families.
not going to work (Score:3)
This treatment is an antibody, not a drug. I don't know why they keep calling it a drug. It is a monoclonal antibody directed against one of the mis-folded proteins found in Alzheimer brains. Limited trials showed a very small positive effect, an effect that will almost certainly disappear when much larger numbers of people taking it are monitored over time. This is about making money more than anything else. It will unfortunately get people's hopes up, without providing any actual benefit.
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A drug is any agent given for the purpose of treating a disease or condition. What the heck else would you call it? A medical device? Pretty sure monoclonal antibodies qualify as a drug just as easily as any other molecule you take that floats around in your blood to act against a disease. As for the efficacy, the data you are referring to is public. You read it, right? If you get dementia and are confident in your own qualifications as an MD and don't want to take that medication it's up to you.Some people
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I am a neuroscientist who specializes in antibodies. They are not drugs, unless of course you are a pharmaceutical company trying to make money on something that won't work. What are your qualifications? Antibodies are very large proteins that bind to specific other proteins or small molecules to target them for immune reaction. And no, I would not take that monoclonal antibody if I got dementia, but you are welcome to. Any treatment for Alzheimer is going to require drugs that prevent the misfolding of pro
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An antibody supplied from an external source *is* a drug. So it's perfectly legitimate usage. It's less specific than "monoclonal antibody", but it's still accurate.
But (IIUC) the benefits are, indeed, quite minor, and probably not enough to be worth the risk of side effects. And it's not really clear (to me) why the FDA approved it.
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Folks can call it what they want, but drugs typically activate or inhibit a receptor, channel, enzyme or other functional protein. They do not just bind to some other protein like antibodies do. Yes, once bound they would attract microglia to the misfolded protein, but that is an antibody function, not a drug. I am sticking with my point that antibodies are large proteins, not drugs. You were correct, people should call them antibodies, since that is what they are. But of course, if you are a drug company,
not going to work (Score:2)
If it walks like brain starvation, behaves like brain starvation, and speaks like brain starvation....
Its treated via a monoclonal antibody targettting a folded protein, thereby making it most likely not work? When said protein is more likely just poorly understood brain plaque that may or may not even be related to poorly understood biochemical processes, as digestion and nutrition alongside the brain's biochemistry keeps being treated like a black box as proper studies generally are limited without access
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This treatment is an antibody, not a drug. I don't know why they keep calling it a drug. It is a monoclonal antibody directed against one of the mis-folded proteins found in Alzheimer brains.
I could be wrong, but what I read about it suggested that it wasn't even that specific; rather, it targets the protein, period, whether misfolded or not.
I could easily see how that approach could work, up to a point. IIRC, studies show that the misfolded proteins aren't the main problem; rather, the problem is lack of an adequate supply of circulating proteins that aren't misfolded. So if the immune system wipes out the normal and mis-folded proteins in large enough quantities, then presumably new, not-mi
Mild Cognitive Impairment? (Score:2)
The indication for this says mild cognitive impairment. What if I'm 40 years old, and I feel the competitiveness in the job marketplace from 20 somethings, so I feel inadequate with my brain recall ability? Am I good to try this super expensive drug? I don't really get what it does to the brain and why there isn't a better test to know when it's use is appropriate. (Obviously, a doctor is a gatekeeper to this, but should I be pounding at the gate?)
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Is your mild cognitive impairment caused by Alzheimer's (or rather the specific protein this drug goes after)?
slim chance this is a good treatment (Score:2)
First off, you are right, antibodies have limited access to the brain parenchyma.(getting past the blood brain barrier (BBB) and into the intercellular space). But apparently some of it does, or you wouldn't have any effect (including increased chance for bleeding in the brain). The brain is a so-called immune privileged site which means that microglia are mostly on their own in defending the brain against infection or other problems. But, if you have a bad brain infection the BBB opens up and you get diape