Posted on 06/07/2021 10:39:54 AM PDT by ChicagoConservative27
“The approved drug, aducanumab”
Great news but lousy name.
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.
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
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.
Bamunacuda sounds better.
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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."
Wait until Vicineum is approved.
It cures bladder cancer.
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.
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.
LOL
But as with Hollywood stars and pop singers, The Big Guy gets a percentage for his likeness on a product. Just a reminder.
Wow, been waiting and hoping for this news. My BIIB stocks have went up $120 per share or 43% today on this news. I hope it’s very successful, this disease is horrifying.
My #!&÷[=$<÷&##& Brother In Law helped my lovely Sister kill herself in the face of Alzheimers 2 years ago.
I will never forgive him.
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.
I pray it is successful also, people with early onset of this horrible disease hopefully can benefit greatly!!
Quick! Send Joe a script!
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.
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.
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.
Aducanumab is the molecule name. Aduhelm will be the trade, or marketed name.
Hush! The people will not be denied their panacea.
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