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FDA Approves ‘First-of-Its-Kind’ Alzheimer’s Treatment
breitbart ^ | 06/07/2021 | Hannah Bleau

Posted on 06/07/2021 10:39:54 AM PDT by ChicagoConservative27

The Food and Drug Administration (FDA) on Monday approved what it described as a “first-of-its-kind” treatment for Alzheimer’s disease, which it says “targets the fundamental pathophysiology of the disease.”

The approved drug, aducanumab, is what the Washington Post described as the “first drug cleared that is designed to alter the course of the disease by slowing the deterioration of brain function — not just to ease symptoms.”

(Excerpt) Read more at breitbart.com ...


TOPICS: Culture/Society; Government; News/Current Events; Your Opinion/Questions
KEYWORDS: aducanumab; aduhelm; alzheimer; alzheimers; approves; biogen; fda; intravenous; treatment
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To: ChicagoConservative27

“The approved drug, aducanumab”

Great news but lousy name.


21 posted on 06/07/2021 11:00:35 AM PDT by plain talk
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To: HonorInPa

I think directed antibodies are the future of tailored medical therapies — it is a very elegant solution. I am with you that I would like to see it work.


22 posted on 06/07/2021 11:02:33 AM PDT by gas_dr (Conditions of Socratic debate: Intelligence, Candor, and Good Will. )
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To: HonorInPa

I’m sorry for your loss. As with covid you go with what you have while developing better treatments. Just because it is t a miracle doesn’t mean it can’t be useful. I hope it provides some relief for many suffering families


23 posted on 06/07/2021 11:02:51 AM PDT by Mom MD ( )
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To: WVNan
Pray that it works safely.

Suppose that it works, but in 10 years your kidneys are wiped out. That's still a win.

I've known two people closely, one being my mother who died of this disease. Anything that helps is a win because the alternative is worse.

24 posted on 06/07/2021 11:06:42 AM PDT by Malsua
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To: plain talk
Great news but lousy name.

Bamunacuda sounds better.

25 posted on 06/07/2021 11:07:16 AM PDT by Fresh Wind (Der Impfstoff macht frei.)
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To: ChicagoConservative27
Hey I know, lets try it on the vaxxers, they'll try anything!

---------------------------------------------------------------------------------------------

.

The FDA Has Approved A New Alzheimer's Drug — Here's Why That's Controversial

"But two large studies offered conflicting evidence about whether the treatment slows declines in memory and thinking. A panel of expert advisers to the FDA recommended in November that the agency not approve the drug.

As a condition of approval, the FDA is requiring Biogen, the drug's maker, to conduct another clinical study to confirm that the reduction of amyloid plaques results in clinical improvement for patients. If the subsequent study doesn't show a clinical improvement, the agency could move to withdraw the approval." https://www.npr.org/2021/06/07/1003964235/fda-approves-controversial-alzheimers-drug-aducanumab

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"The prescribing information includes another warning about hypersensitivity reactions, including angioedema and urticaria. The most common side effects associated with Aduhelm involved ARIA, headache, fall, diarrhea and confusion/delirium/altered mental status/disorientation."

https://www.healio.com/news/neurology/20210607/fda-approves-aduhelm-first-new-alzheimers-disease-treatment-since-2003

26 posted on 06/07/2021 11:09:08 AM PDT by Karl Spooner
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To: ChicagoConservative27

Wait until Vicineum is approved.

It cures bladder cancer.


27 posted on 06/07/2021 11:10:54 AM PDT by Cowgirl of Justice
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To: ImJustAnotherOkie

Biden: “Holy cow. I’m gonna run right in to tell President Obama at the White House. Wait, that orange guy is in there. But what was it I just wanted to tell somebody? Something.....

“Dr.” Jill (EdD): Shut up and go back to your naptime, Joey.


28 posted on 06/07/2021 11:14:06 AM PDT by frank ballenger (You have summoned up a thundercloud. You're gonna hear from me. Anthem by Leonard Cohen)
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To: ChicagoConservative27

New York Times

The Food and Drug Administration on Monday approved the first new medication for Alzheimer’s disease in nearly two decades, a contentious decision, made despite opposition from the agency’s independent advisory committee and some Alzheimer’s experts who said there was not enough evidence that the drug can help patients.

Recognizing that clinical trials of the drug had provided incomplete evidence to demonstrate effectiveness, the F.D.A. granted approval on the condition that the manufacturer, Biogen, conduct a new clinical trial.

During the several years it could take for that trial to be concluded, the drug will be available to patients, the agency said. If the post-market study, called a Phase 4 trial, fails to show the drug is effective, the F.D.A. can — but is not required to — rescind its approval.


29 posted on 06/07/2021 11:14:47 AM PDT by Cathi
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To: Beagle8U
Bye-Done’s picture on the label.

LOL

But as with Hollywood stars and pop singers, The Big Guy gets a percentage for his likeness on a product. Just a reminder.

30 posted on 06/07/2021 11:15:42 AM PDT by frank ballenger (You have summoned up a thundercloud. You're gonna hear from me. Anthem by Leonard Cohen)
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To: gas_dr

Wow, been waiting and hoping for this news. My BIIB stocks have went up $120 per share or 43% today on this news. I hope it’s very successful, this disease is horrifying.


31 posted on 06/07/2021 11:17:45 AM PDT by chuck allen
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To: ChicagoConservative27

My #!&÷[=$<÷&##& Brother In Law helped my lovely Sister kill herself in the face of Alzheimers 2 years ago.

I will never forgive him.


32 posted on 06/07/2021 11:24:30 AM PDT by Uncle Miltie (I'm changing my name to 'Spike Protein'!)
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To: Uncle Miltie

But at least he gets to continue to sponge off of her Social Security since he refused to get a paying job for the last 30 years. MFer.


33 posted on 06/07/2021 11:26:34 AM PDT by Uncle Miltie (I'm changing my name to 'Spike Protein'!)
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To: chuck allen

I pray it is successful also, people with early onset of this horrible disease hopefully can benefit greatly!!


34 posted on 06/07/2021 11:31:09 AM PDT by Trump Girl Kit Cat (Yosemite Sam raising hell)
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To: ChicagoConservative27

Quick! Send Joe a script!


35 posted on 06/07/2021 11:33:34 AM PDT by Real Cynic No More (Make America Great. Prosecute Dems who break the law!)
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To: Karl Spooner

Good post.

Patients receiving the treatment had significant dose-and time-dependent reduction of amyloid beta plaque, while patients in the control arm of the studies had no reduction of amyloid beta plaque.

Notice the article says nothing about improving the mental state of the patients, or reducing the memory loss. Amyloid beta is not the cause the problem Amyloid beta is the result of the real cause, and is produced by the body to solve the real problem.


36 posted on 06/07/2021 11:34:28 AM PDT by aimhigh (THIS is His commandment . . . . 1 John 3:23)
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To: aimhigh
Notice the article says nothing about improving the mental state of the patients, or reducing the memory loss. Amyloid beta is not the cause the problem

I think they know that now, too. But at least they get to recoup their research money they wasted on their theory this way. FDA takes care of their own.

37 posted on 06/07/2021 11:39:42 AM PDT by Karl Spooner
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To: aimhigh

But the F.D.A. advisory committee, along with an independent think tank and several prominent experts — including some Alzheimer’s doctors who worked on the aducanumab clinical trials — said the evidence raised significant doubts about whether the drug is effective. They also said that even if aducanumab could slow cognitive decline in some patients, the benefit suggested by the evidence would be so slight that it would not outweigh the risk of swelling or bleeding in the brain that the drug caused in the trials.


38 posted on 06/07/2021 11:56:33 AM PDT by Cathi
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To: plain talk
Great news but lousy name.

Aducanumab is the molecule name. Aduhelm will be the trade, or marketed name.

39 posted on 06/07/2021 12:06:02 PM PDT by Lou L (Health "insurance" is NOT the same as health "care")
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To: Cathi
They also said that even if aducanumab could slow cognitive decline in some patients, the benefit suggested by the evidence would be so slight that it would not outweigh the risk of swelling or bleeding in the brain that the drug caused in the trials.

Hush! The people will not be denied their panacea.

40 posted on 06/07/2021 12:11:01 PM PDT by Karl Spooner
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