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

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.

RE: Wow! that’s a lot of cheddar. Look for medicare rates to double.

It is because Biogen has to recoup the MONEY THEY SPENT on all phases of trials required by the FDA.

This is true of every drug that gets approved by the FDA that needs to go through all phases of trials required, and there’s no guarantee of success in every phase.

You name it — cancer, diabetes, heart disease, Alzheimer’s ( with the exception of Covid vaccines ), companies have to spend hundreds of millions to go through all phases. They’re not going to just give it out for free, unless the government pays them for it like they did with the Covid vaccines.

"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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Sounds like it gives you Alzheimer to cure Alzheimer’s disease.

"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

Another payday for drug companies with no proof this will even work but people will want to believe.snip'''

When you are facing a down hill all the way all the time, with a loved one who has Alzheimer's , you should realize it is hopeless, and can't be stopped by anyone in the medical profession or clergy or by prayers to some supernatural being.

So you grasp at anything that might slow it down. Donepezil aka Aricept, and Mementine aka Namenda, are two drugs that are used to slow Alzheimer's down. Do they help? Who knows?

But a caretaker can't take the chance they won't help.

Looks like another new drug is coming along in that category. -Tom

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