6 ms·

US approves first new Alzheimer's drug in 20 years

CharleFKane 5y ago
Derek Lowe posted about this on Friday: "A Brief Note About Aducanumab" https://blogs.sciencemag.org/pipeline/archives/2021/06/03/a-brief-note-about-aducanumab https://blogs.sciencemag.org/pipeline/archives/2021/06/03/a-... "Given the current data, I do not think that aducanumab should be approved. I don’t believe that Biogen’s clinical trials have really demonstrated efficacy against the disease, and the FDA briefing documents show that there are many people in the agency who agree with that position..."
maxk42 5y ago
Interesting that this is the first approved drug to target amyloid plaques. Is most treatment targeted at symptoms instead?
- jcranmer 5y ago
  No, all prior attempts (that I'm aware of) have been to target amyloid plaques--amyloid hypothesis has been the big working hypothesis of Alzheimer's for decades. That they all failed has caused most in the field to abandon the hypothesis, and the fact that this is an amyloid blocker has most people expecting this to fail. Indeed, the expert advisory committee at the FDA itself recommended against approving the drug, since the data on improving actual Alzheimer's progression is at best equivocal, especially given the past history of amyloid blockers. The FDA granted it essentially saying "there's nothing else there that works, and this does clearly clear amyloid plaques" (ignoring prior drugs that clearly cleared amyloid plaques yet still didn't work). And many people, including myself, are now preparing for the country to spend tens of billions on a drug which very probably doesn't work. This does not paint the FDA in a good light.
  - eurasiantiger 5y ago
    It is corruption. Pure and simple.
  - cameronh90 5y ago
    Although the FDA seem to be going against their brief - that is, only approving something that works and has acceptable risks - maybe that's not a bad thing. Playing devil's advocate, would it be preferable if the FDA just validated the manufacturer's claims were true rather than applied a value judgement on the drug? That way, even if it turns out this (and other similar) drug isn't useful for Alzheimer's in general, but if it turns out amyloid plaque clearing is found to have an actual use, then this drug could be immediately used? In a sense, embracing the "off label" use of medication that's already prevalent throughout medicine. I don't know whether this would make medicine better or not, but deciding on the risk vs benefit of a particular treatment is something that should be done between a patient and a doctor, provided they have access to all necessary information to make that decision and the claims made by the manufacturer are known to be valid.
    - jcranmer 5y ago
      > Playing devil's advocate, would it be preferable if the FDA just validated the manufacturer's claims were true rather than applied a value judgement on the drug? The manufacturer's claims here are that the drug treats Alzheimer's. That's the key claim here that everyone cares about; the amyloid plaque-clearing part of it only matters insofar as it's hoped to be the key to Alzheimer's treatment. There's another factor to point out: strictly speaking, this drug is only approved conditional on a further clinical trial proving efficacy (which will take years because Alzheimer's trials take forever). Now take stock of how many headlines mention that fact, or even hint at the sharp disagreement (what an understatement) about the efficacy of the drug.
      - cameronh90 5y ago
        "The manufacturer's claims here are that the drug treats Alzheimer's. " I know, it was just a bit of an aside. The reason they presumably claim this is because if they just claimed it cleared amyloid plaques, that wouldn't be approved by the FDA as it's not treating a condition?
missedthecue 5y ago
Insurers (whether companies or government schemes) will only have to pay $56,000 a year for this treatment. I wonder how much the FDA increases healthcare costs. Biogen has been trying to get the approved for a very long time. I'm sure they're starting out maybe five to ten billion in the red on this product.
- olliej 5y ago
  The FDA doesn't meaningfully impact costs, unless you include "testing to make sure it's safe" as a cost. I would have said efficacy as well, except the evidence doesn't suggest that this drug does anything except empty people's wallets in exchange for false hope.
- brianwawok 5y ago
  It’s not the FDAs job to approve or not things based on price. It’s their job to approve things that are safe and effective. Imagine a world where a pill was made to cure all cancer, but not approved because the price was too high.
  - missedthecue 5y ago
    I'm not saying they should regulate price, just that they are a pretty significant barrier to entry, cost a lot of American lives through inaction, and seem to miss and even endorse plenty of dangerous drugs anyway.
- oldgradstudent 5y ago
  Manufacturers price their product to maximize profits, regardless of the sunk costs. If they have thought pricing it at $100,000/year would have brought more profits they would have priced it at $100K, and if they thought pricing it at $25,000/year would have brought more profits they would have priced it at $25K.
tibbydudeza 5y ago
6 million Alzheimer patients in the US ... can see why it was approved. The advisory panel voted 8-1 against approval - as it was not effective. https://www.youtube.com/watch?v=ShGXKrY8kZA https://www.youtube.com/watch?v=ShGXKrY8kZA
- mithusingh32 5y ago
  But out or those 6 million, who can actually afford it? The US has shown a general lack of care for it's citizens health. I honestly wouldn't be shocked of this was just a way for biogen to have a massive spike in their stock so it's holders can cash out.
  - JumpCrisscross 5y ago
    > US has shown a general lack of care for it's citizens health The American health system has its problems. But this is an odd accusation to level against the country that played a foundational role in developing, distributing and administering highly-effective and novel Covid vaccines to a world-leading fraction of its population. These systems have strengths and weaknesses. Broad measures of "good" or "bad" are too lossy.
    - redis_mlc 5y ago
      > But this is an odd accusation to level against the country that played a foundational role in developing, distributing and administering highly-effective and novel Covid vaccines to a world-leading fraction of its population. Get your story straight. Obama/Fauci funded the development of corona, and Trump funded the vaccines.
  - deepnotderp 5y ago
    Ironically it’s usually these types of new drugs that are least available under universal healthcare systems aiui
eqvinox 5y ago
20 years... so, the patents on the previous generation are running out, are they? (I seriously hope this is excessive cynicism on my part, but I vaguely remember reading articles like https://www.mondaq.com/india/patent/768712/pharma-companies-extend-patent-life-with-slight-modifications https://www.mondaq.com/india/patent/768712/pharma-companies-... [have not read this particular one, just the first thing I found googling...])

Derek Lowe posted about this on Friday: "A Brief Note About Aducanumab" https://blogs.sciencemag.org/pipeline/archives/2021/06/03/a-brief-note-about-aducanumab https://blogs.sciencemag.org/pipeline/archives/2021/06/03/a-... "Given the current data, I do not think that aducanumab should be approved. I don’t believe that Biogen’s clinical trials have really demonstrated efficacy against the disease, and the FDA briefing documents show that there are many people in the agency who agree with that position..."

maxk42 5y ago

Interesting that this is the first approved drug to target amyloid plaques. Is most treatment targeted at symptoms instead?

jcranmer 5y ago
No, all prior attempts (that I'm aware of) have been to target amyloid plaques--amyloid hypothesis has been the big working hypothesis of Alzheimer's for decades. That they all failed has caused most in the field to abandon the hypothesis, and the fact that this is an amyloid blocker has most people expecting this to fail. Indeed, the expert advisory committee at the FDA itself recommended against approving the drug, since the data on improving actual Alzheimer's progression is at best equivocal, especially given the past history of amyloid blockers. The FDA granted it essentially saying "there's nothing else there that works, and this does clearly clear amyloid plaques" (ignoring prior drugs that clearly cleared amyloid plaques yet still didn't work). And many people, including myself, are now preparing for the country to spend tens of billions on a drug which very probably doesn't work. This does not paint the FDA in a good light.
- eurasiantiger 5y ago
  It is corruption. Pure and simple.
- cameronh90 5y ago
  Although the FDA seem to be going against their brief - that is, only approving something that works and has acceptable risks - maybe that's not a bad thing. Playing devil's advocate, would it be preferable if the FDA just validated the manufacturer's claims were true rather than applied a value judgement on the drug? That way, even if it turns out this (and other similar) drug isn't useful for Alzheimer's in general, but if it turns out amyloid plaque clearing is found to have an actual use, then this drug could be immediately used? In a sense, embracing the "off label" use of medication that's already prevalent throughout medicine. I don't know whether this would make medicine better or not, but deciding on the risk vs benefit of a particular treatment is something that should be done between a patient and a doctor, provided they have access to all necessary information to make that decision and the claims made by the manufacturer are known to be valid.
  - jcranmer 5y ago
    > Playing devil's advocate, would it be preferable if the FDA just validated the manufacturer's claims were true rather than applied a value judgement on the drug? The manufacturer's claims here are that the drug treats Alzheimer's. That's the key claim here that everyone cares about; the amyloid plaque-clearing part of it only matters insofar as it's hoped to be the key to Alzheimer's treatment. There's another factor to point out: strictly speaking, this drug is only approved conditional on a further clinical trial proving efficacy (which will take years because Alzheimer's trials take forever). Now take stock of how many headlines mention that fact, or even hint at the sharp disagreement (what an understatement) about the efficacy of the drug.
    - cameronh90 5y ago
      "The manufacturer's claims here are that the drug treats Alzheimer's. " I know, it was just a bit of an aside. The reason they presumably claim this is because if they just claimed it cleared amyloid plaques, that wouldn't be approved by the FDA as it's not treating a condition?

missedthecue 5y ago

Insurers (whether companies or government schemes) will only have to pay $56,000 a year for this treatment. I wonder how much the FDA increases healthcare costs. Biogen has been trying to get the approved for a very long time. I'm sure they're starting out maybe five to ten billion in the red on this product.

olliej 5y ago
The FDA doesn't meaningfully impact costs, unless you include "testing to make sure it's safe" as a cost. I would have said efficacy as well, except the evidence doesn't suggest that this drug does anything except empty people's wallets in exchange for false hope.
brianwawok 5y ago
It’s not the FDAs job to approve or not things based on price. It’s their job to approve things that are safe and effective. Imagine a world where a pill was made to cure all cancer, but not approved because the price was too high.
- missedthecue 5y ago
  I'm not saying they should regulate price, just that they are a pretty significant barrier to entry, cost a lot of American lives through inaction, and seem to miss and even endorse plenty of dangerous drugs anyway.
oldgradstudent 5y ago
Manufacturers price their product to maximize profits, regardless of the sunk costs. If they have thought pricing it at $100,000/year would have brought more profits they would have priced it at $100K, and if they thought pricing it at $25,000/year would have brought more profits they would have priced it at $25K.

tibbydudeza 5y ago

6 million Alzheimer patients in the US ... can see why it was approved. The advisory panel voted 8-1 against approval - as it was not effective. https://www.youtube.com/watch?v=ShGXKrY8kZA https://www.youtube.com/watch?v=ShGXKrY8kZA

mithusingh32 5y ago
But out or those 6 million, who can actually afford it? The US has shown a general lack of care for it's citizens health. I honestly wouldn't be shocked of this was just a way for biogen to have a massive spike in their stock so it's holders can cash out.
- JumpCrisscross 5y ago
  > US has shown a general lack of care for it's citizens health The American health system has its problems. But this is an odd accusation to level against the country that played a foundational role in developing, distributing and administering highly-effective and novel Covid vaccines to a world-leading fraction of its population. These systems have strengths and weaknesses. Broad measures of "good" or "bad" are too lossy.
  - redis_mlc 5y ago
    > But this is an odd accusation to level against the country that played a foundational role in developing, distributing and administering highly-effective and novel Covid vaccines to a world-leading fraction of its population. Get your story straight. Obama/Fauci funded the development of corona, and Trump funded the vaccines.
- deepnotderp 5y ago
  Ironically it’s usually these types of new drugs that are least available under universal healthcare systems aiui

eqvinox 5y ago

20 years... so, the patents on the previous generation are running out, are they? (I seriously hope this is excessive cynicism on my part, but I vaguely remember reading articles like https://www.mondaq.com/india/patent/768712/pharma-companies-extend-patent-life-with-slight-modifications https://www.mondaq.com/india/patent/768712/pharma-companies-... [have not read this particular one, just the first thing I found googling...])