FDA delays Alzheimer’s wonder-drug, likely out of corruption

The FDA has delayed a revolutionary Alzheimer’s drug from coming to market apparently in favor of a dangerous Alzheimer’s drug that causes brain-bleeding.

The FDA very quickly approved a dangerous Alzheimer’s drug that was marketed by two pharmaceutical mega-corporations called Biogen and Eisai.

That drug is Leqembi. The FDA had already approved another brain-damaging Alzheimer’s drug from Biogen called Aduhelm, which seemed to show little or no clinical effectiveness.

When the FDA had the opportunity to quickly approve a safe and more effective Alzheimer’s drug invented by a small corporation, it apparently required that company to jump through more hoops, delaying the drug by who knows how long; it’s still in limbo.

This safter, better drug is Blarcamesine, developed by Anavex Life Sciences.

Context: Biogen developed an Alzheimer’s drug called Aduhelm that many doctors claimed did not work. In order to get the drug approved by the FDA, Biogen held secret meetings with FDA decision-makers, likely to exchange favors. Months later, a Congressional investigation uncovered the secret, unethical, and possibly illegal secret meetings, but NO ONE WAS PUNISHED OR FIRED at the FDA.

Aduhelm was granted accelerated approved, but to this day, doctors have very little interest in administering the drug to patients because it likely does not work, and it causes brain bleeding in a major portion of patients.

More context. Biogen then developed another Alzheimer’s drug. This one, Leqembi, did demonstrate effectiveness in slowing down cognitive decline in people developing dementia. That was demonstrated in their pivotal Phase 3 trial. Also demonstrated in that Phase 3 trial was the “biomarker” evidence, namely that Leqembi lowered amyloid levels in the brain; increased amyloid is associated with worsening dementia.

The problem with Leqembi is, again, it causes brain bleeding in a major portion of patients. In a six-month extension trial study of that Phase 3 trial, a number of patients developed brain bleeding, and THREE OF THEM DIED.

Interestingly, just THREE MONTHS after Biogen presented the Phase 3 data to the world, the FDA granted emergency (accelerated) approval to Biogen for Leqembi. As a sidenote, Biogen, Eisai, the FDA, and the Alzheimer’s Association acted like nobody died and essentially covered up the deaths of the Alzheimer’s patients. More on that in a future article.

Comparison. A much, much smaller company named Anavex developed a much safer Alzheimer’s drug called Blarcamesine (Anavex 2–73). It does not cause brain bleeding and will likely be much cheaper than Leqembi. It does not require biweekly IV-infusions at the hospital, nor does it require multiple MRI tests for brain bleeding at the hospital, like Leqembi does.

Furthermore, Blarcamesine works much better and faster than Leqembi, and seems to actually improve brain function for many who take it. There seem to be super-responders who, upon taking Blarcamesine for 48 weeks (length of the Phase 3 trial) improved their ADAS-Cog13 test scores by multiple points. That test is a measure of one’s ability to think and remember. For a dementia patient to improve by multiple points over the course of a year is essentially a miracle. After all, the typical Alzheimer’s patient gets worse by a point each year; and some decline faster than that!

On average, Blarcamesine slows down cognitive decline by 45% over the course of 48 weeks. This delays the onset of full-blown Alzheimer’s dementia by years if the slowing effect is sustainable.

Furthermore, Blarcamesine causes ZERO brain bleeding because it works differently than the Biogen drugs. It helps the brain regain its own self-regulating functions rather than attack or destroy certain organic materials in the brain.

Finally, Blarcamesine will likely cost a fraction of the $26,500 annual price of Leqembi.

What one would expect. Seeing a safe and effective Alzheimer’s drug is seeing a unicorn. It just does not happen. Until now. One would expect the FDA to bend over backwards to speed up public access to this drug, Blarcamesine.

Instead, apparently, the FDA has been putting the brakes on Blarcamesine. The FDA is apparently requiring that Anavex finish their two-year Blarcamesine extension study in order to apply for emergency (acclerated) approval for this desperately needed drug. Anavex must not only finish the study but present a compelling statistical analysis to the FDA regarding the findings.

The FDA did not require Biogen to finish their 6-month extension study; nor did the FDA require Biogen to present any statistical findings, successful or not, from that 6-month extension study, perhaps because three people in that study died from the drug.

The FDA only required Biogen to present compelling “biomarker” data from their Phase 3 study, and, abracadabra, three months later, Leqembi was approved.

Anavex presented “biomarker” data from its Phase 3 study in September, and in some ways their “biomarker” data is more compelling than that of Leqembi. Not only did Blarcamesine lower amyloid levels in the brain, but it also slowed the shrinking of the brains of participants.

When I looked at my mother’s brain MRIs it was clear she was suffering from Alzheimer’s because her brain had shrunk and was “rotting away” throughout. Blarcamesine looks to be the first drug ever to prevent the brain from shrinking or rotting away (my non-clinical way of putting it).

With this “biomarker” data in hand, one would expect the FDA to rush towards emergency approval, and we would have had a wonderful gift by Christmas, 2023: a safe, much cheaper, and far more effective Alzheimer’s drug.

At this point, it’s not clear exactly when we can get access to Blarcamesine. Anavex’s CEO stated during a conference call that the extension study should end this year (2023); but this one-time statement is not that assuring to me.

Furthermore, after Anavex finishes the extension study they must present the results to the FDA along with all of their Phase 3 data. Putting together that package could take weeks or months.

And then the FDA may take their sweet time in analyzing the data. It’s not guaranteed that the FDA will take only three months to approve Blarcamesine, like it did for Leqembi.

After all, FDA decision-makers and biotech mega-corporations hold secret meetings for a reason. You scratch my back, I guarantee you a 7-digit package when you leave your FDA post and work for us.

Every month during which Leqembi is the sole effective (but dangerous) Alzheimer’s drug on the market, Biogen and Eisai are set to earn billions in revenue. The instant Blarcamesine hits the market, Biogen and Eisai will lose billions in potential revenues each month. Their drug costs patients and the government $26,500 per year, not counting the biweekly infusions and multiple brain MRIs. There are over 6.7 million Alzheimer’s patients in the United States. Multiply the two numbers and you get $177 BILLION in potential annual revenues.

You scratch my back, I get you whatever you need, as long as it’s less than $50 billion — we gotta make our money too, right?

Here’s the good news. The EU is already deciding on whether to approve Blarcamesine, but the EU is typically slow, taking over a year to approve many drugs. However, the scientists and regulators in Europe know too the urgent need for the drug, and they may quicken their pace.

A final note. If the FDA approves Blarcamesine for the treatment of Rett Syndrome next year, Alzheimer’s patients may be able to buy Blarcamesine “off-label” with a prescription from their neurologist.

In the meantime, contact your Senator and the Alzheimer’s Association. Ask them why the government and the NGO’s are not pushing for Blarcamesine like they did for Leqembi.