Yesterday, the FDA approved for use the monoclonal antibody (mab) treatment lecanemab (code named BAN2401) via their "accelerated approval process." This is kind of like the process that got them in trouble with aducanumab, but I doubt they will face the same headwinds. For one thing, their approval doesn't fly in the face of the advice of the Peripheral and Central Nervous System Drugs Advisory Committee. You'll recall what happened with aducanumab.
So now Biogen and Esai will market lecanemab as Leqembi. How well will this go? For starters, the wholesale price will be another $26,500 per year. That doesn't include the periodic MRIs to check for brain swelling and microhemorrhages. And did I mention three people died during clinical trials? Oh -- yes I did. What will the insurance companies say about paying for it? What will Medicare say? We shall see.
How do Biogen and Esai justify the price? In this statement, they say it's based on the value of the treatment to society -- their concept of the "societal value of medicine" in relation to the "price of medicine." If history is a guide, Elizabeth Warren and a few others will offer their thoughts on how that should work.
While the "mabs," like Aduhelm and Leqembi, go beyond treating symptoms, we don't know that they are treating the cause (or causes) and mechanisms of the disease. We just don't really understand those very well. And so these are not cures, they simply slow the progress of Alzheimer's disease.
Will the pros outweigh the cons for many people? If you slow the disease enough to add a few good years to someone's life, maybe so.
The fact that it allegedly killed three people during the clinical trials would be enough to make me run the other way. Supposedly, the first two died because of comorbidities, but the third died FROM the drug.
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