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written by reader Easai – Promising Alzheimer’s Drug?

By reneeweaver, February 10, 2022

I saw this in Alzheimer’s research news. I wondered if Eisai looks like a strong company. Robinhood gives it 50% hold, 25% buy, 25%sell.
From the Field: Aducanumab Approved for Treatment of Alzheimer’s disease (AD)

On June 2021, the US Food and Drug Administration (FDA) gave ‘accelerated approval’ for the anti-amyloid drug aducanumab, which is the first therapy drug to demonstrate that removing amyloid from the brain is reasonably likely to reduce cognitive and functional decline in people living with early Alzheimer’s. An amyloid is a protein plaque that builds in the brain and is believed to be associated with Alzheimer’s disease.

Although the decision of approving aducanumab has been controversial, the drug is now being reviewed by the Centers for Medical Services (CMS) with regards to its coverage by Medicare. The ‘accelerated approval’ pathway is available under federal law when a drug intended for a serious disease is expected to provide a meaningful advantage over available treatments. A drug may be approved under this pathway when it has shown it can improve a measure of a particular disease and when it is “reasonably likely” that this measure predicts clinical benefit. In the case of aducanumab, that measure, believed to be reasonably likely to predict clinical benefit, is brain amyloid. The drugmaker Eisai has announced that it plans to apply for accelerated approval of another anti-amyloid drug, lecanemab, that has shown clear results in its ability to reduce brain amyloid. In a study of 856 participants, lecanemab significantly reduced brain amyloid and a late-stage clinical trial of 1,795 participants called Clarity-AD is ongoing to determine if there is also a cognitive benefit associated with the drug. The AHEAD Study is another clinical trial of lecanemab being evaluated in persons who have elevated brain amyloid but no symptoms of dementia. This study is based on the idea that earlier treatment of elevated brain amyloid provides the greatest likelihood of clinical benefit. We will keep you informed on these studies as results become available.

I have two shares of Biogen already. What are other people’s thoughts on both Biogen and Eisai?

This is a discussion topic or guest posting submitted by a Stock Gumshoe reader. The content has not been edited or reviewed by Stock Gumshoe, and any opinions expressed are those of the author alone.

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Mike
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Mike
February 13, 2022 8:02 am

I think the plaque theory is dead. Biogens drug has proved that. It also has serious side effects. Now that big pharma has basically agreed that plaque is dead we can move ahead to many more promising theories. The best one I have found which is the farthest along is Anavex Life Sciences ($AVXL) which has recently completed a phase 3 for Rett Syndrom – ANAVEX®2-73 (Blarcamesine) AVATAR Phase 3 Trial met Primary and Secondary Efficacy Endpoints for the Treatment of Adult Patients with Rett Syndrome.

What does this have to do with Alzheimers disease? They use the same drug (2-73) for the pivotal Alzheimers Disease trial in phase 2/3 right now and Parkinsons Disease Dementia. They use Sigmar 1 -ANAVEX®2-73 MoA: SIGMAR1 Activation Prevents Cellular Stress Before and After Gene Transcription.

They have never failed a trial – they have shown MOA in most all CNS disorders including AD, PD, Rett syndrome and planning for Fragile X – which is the factor in Autism Spectrum Disorder.
Go to there website and look at the latest presentation and listen to the 1Q22 financial CC where they give an update on the Rett Trial readout. Yes Adam F. tried to take it all down but look and listen – do your DD. This company is solid – has solid science and will be the answer to most if not all CNS(Central Nervous System) disorders. Epilipsy, LGD, PD, AD, Autism, Rett syndrome , FTD, Schizophrenia, Anglemans syndrome, Fragile X.

https://www.anavex.com/

You’re welcome.

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