FDA Approves Biogen Alzheimer’s Drug: First treatment to attack a likely cause of Alzheimer’s disease

Reuters via Epoch Times ^ | 06/07/2021

[SeekAndFind]

Government health official on Monday approved Biogen’s aducanumab as the first treatment to attack a likely cause of Alzheimer’s disease, sending its shares soaring, despite controversy over whether the clinical evidence proves the drug works.

Biogen said it has priced the drug, to be sold as Aduhelm, at $56,000 per year. Its shares jumped nearly 52 percent to $434.52 when trading resumed following the approval. U.S. traded shares of partner Eisai Co were already up $33.50, or 45 percent, to $107.75

Aducanumab aims to remove sticky deposits of a protein called amyloid beta from the brains of patients in earlier stages of Alzheimer’s in order to stave off its ravages, which include memory loss and the inability to care for one’s self.

“This is good news for patients with Alzheimer’s disease. We’ve not had a disease modifying therapy approved ever,” said Dr. Ronald Petersen, an Alzheimer’s disease expert at the Mayo Clinic. However, he cautioned, “This is not a cure. It’s hoped that this will slow the progression of the disease.”

“I think this is a big day,” Peterson said. “But we can’t overpromise.”

Alzheimer’s is the sixth leading cause of death in the United States.

The Food and Drug Administration (FDA) on its website noted that trials data for the treatment was complicated with respect to clinical benefits, but added that it “has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients.”

Biogen’s drug had been hailed by patient advocates and some neurologists eager to have an effective option for patients with the lethal disease. Other doctors said clinical trial results were inconsistent and more proof was needed.

[Pining_4_TX]

I think they are grasping at straws, but I can’t blame people for trying to find something that will treat this dreadful disease. The drugs they use now don’t help really, so I’m skeptical that this one will amount to anything.

[vikingd00d]

>>They have 30 years to recoup their R&D. They don’t need to recoup it at n the first 6 months.

But as soon as they try to apply for international patents, places like Canada will demand they sell it for only the marginal cost or else they’ll break the patent. It’s only Americans that have to pay for the R&D.

[P-Marlowe]

FWIW, I don’t take drugs that haven’t been around long enough to go generic.

[Captain Peter Blood]

I have a 94 year old aunt I take care of with dementia and confusion problems. Her neurologist told me years ago that none of those drugs you mentioned did little or nothing.

I put her on Vitamin D and I think she has done better.

[Captain Peter Blood]

A great deal of the research for new drugs is done by the NIH, universities, etc., not the drug companies themselves

If I needed that new drug I could get it overseas for pennies on the dollar rather than here.

[SeekAndFind]

RE: $56,000 per year?

Yes, the challenge is to make this affordable for all, like the Covid-19 vaccine.

[Captain Peter Blood]

And who will be able to afford that?

[Capt. Tom]

I have a 94 year old aunt I take care of with dementia and confusion problems. Her neurologist told me years ago that none of those drugs you mentioned did little or nothing.

I put her on Vitamin D and I think she has done better.

Not all dementia is caused by Alzheimer's. But if it is, you will be facing them drifting into another world with delusions and hallucinations along with confusion.

There will be recent memory loss, and I don't mean like yesterday, it can be 5 minutes ago.

Then it will drift into long term memory loss and starvation is the end game. - Tom

[NonValueAdded]

How are “sticky” deposits of a protein called amyloid beta diagnosed?

[caww]

Not convinced drugs do anything but possibly delay early on the ultimate misery people with this disease suffer through...if that. And they already using those types to delay.

It’s beyond a dastardly disease...it’s insufferable.

[caww]

Actually the brain mechanism that instructs swallowing shuts off.....food goes down but can enter the lungs which bring on pneumonia they often die from. With most any terminal disease when the individual is on their way out of this world 'the body' knows it no longer needs nutrients to sustain itself..

[spokeshave]

The only way to be sure is a brain scan.....it can identify the signature pattern of various types of dementia.

[krogers58]

$56,000 per year

Wow! that's a lot of cheddar. Look for medicare rates to double. And it is not even proven to work?

Medicare won't pay for this drug for many years, and it will have to demonstrate that it is worthwhile (saves more money on medical costs/extends life) before they will approve this.

Private insurance is kind of an all over the place proposition, some may, and some may not, depending on how good your insurance is. If you're a former gov't or union employee, it probably will pay. It won't be pretty, and likely only the wealthy will be able to afford this initially.

[montag813]

Sheesh. Just eat more avacados, olive oil, butter, eggs, coconut, etc. Saturated fats and omega 3 rich oils which are neuroprotective. “Experts” in the 60s and 70s doomed an entire generation to record dementia rates by calling those foods poison and convincing tens of millions to eat REAL poison such as “margarine”.

[JohnBrowdie]

are you suggesting that Alzheimer’s is a result of a deficient diet?

[Jane Long]

First glance I thought it said Biden Alzheimer drug.

😱

Pray this is a needed blessing, for many.

[HotKat]

Perhaps I’ve missed something. I thought the only definitive test for Alzheimer’s was done during an autopsy.

[montag813]

are you suggesting that Alzheimer’s is a result of a deficient diet?

The increasing, unprecedented incidence rate? Yes. Of course.

[montag813]

FYI: Dementia expert says evidence behind Biogen Alzheimer’s drug ‘wasn’t sufficient’ for FDA approval

[Antioch]

...or, you could simply take NAC (n acetyl cysteine), ALC (acetyl carnitine) and Nicotinamide (B3) for pennies per day and get the same effect with none of the side effects.