Alzheimers medication approved by FDA

Stateguy

Stateguy

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I’ve been following this for quite some time and purchased a quite a few shares of their stock a while back. They halted trading on it today but looking to see how high it goes. Biogen has made me quite a bit of $ over the years.


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22Rimfire said:
I’ve been following this for quite some time and purchased a quite a few shares of their stock a while back. They halted trading on it today but looking to see how high it goes. Biogen has made me quite a bit of $ over the years.


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Trending upwards of 47%
 
I used to place engineers all the way up to the Director of Facilities Engineering at that outfit. First class biotech. Hope the drug pans out. Lots of Alzheimer’s on my wife’s side. Scares her to death.
 
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fieldgrade said:
I used to place engineers all the way up to the Director of Facilities Engineering at that outfit. First class biotech. Hope the drug pans out. Lots of Alzheimer’s on my wife’s side. Scares her to death.
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My mom's oldest sister, and a brilliant woman, had Alzheimer's. As you well know it's a horrendous way to die.

As for this drug, part of the controversy is that clinical trials showed very little evidence that it works, which, coupled with it's price ($10K low end, $50K high end), isn't going to make it very popular.
 
I guess I’m somewhat confused. The FDA approved it, but with the caveat they run another clinical trial?
 
Chuckman said:
Did they? (request another CT)

I have heard stuff on the rumor mill about it, and I read this earlier: https://www.foxbusiness.com/lifestyle/fda-approves-biogens-alzheimers-drug

Here's another: https://www.cnbc.com/2021/06/07/fda...py-for-the-disease-in-nearly-two-decades.html
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From the article in the OP.

"The FDA said it will continue to monitor the drug as it reaches the U.S. market. The agency granted approval on the condition that Biogen conduct another clinical trial."
 
fieldgrade said:
From the article in the OP.

"The FDA said it will continue to monitor the drug as it reaches the U.S. market. The agency granted approval on the condition that Biogen conduct another clinical trial."
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Reading between the lines, FDA was pushed to bring it to market in spite of less-than-stellar data from the other CTs, and now they are having second thoughts?

I had asked one of our neurologists about it when I saw the news about it a while back and he said (paraphrasing) unless they get better outcomes we (his group) won't prescribe it.
 
The FDA granted an accelerated approval pathway – It looks like they approved it based on a surrogate endpoint, but the company still has to prove by an accepted endpoint (which probably takes a lot longer) that it works.

Attached is the FDA accelerated approval.
this link Information on Aduhelm will list adverse reactions and warnings.


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FDA Grants Accelerated Approval for Alzheimer’s Drug​

Today, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.
Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s disease. It is the first new treatment approved for Alzheimer’s since 2003 and is the first therapy that targets the fundamental pathophysiology of the disease.
The prescribing information for Aduhelm includes a warning for amyloid-related imaging abnormalities (ARIA), which most commonly presents as temporary swelling in areas of the brain that usually resolves over time and does not cause symptoms, though some people may have symptoms such as headache, confusion, dizziness, vision changes, or nausea. Another warning for Aduhelm is for a risk of hypersensitivity reactions, including angioedema and urticaria. The most common side effects of Aduhelm were amyloid-related imaging abnormalities (ARIA), headache, fall, diarrhea, and confusion/delirium/altered mental status/disorientation.
Related Information:
 
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