Approved

[anonymous]

FDA Approves Eisai and Biogen’s New Alzheimer’s Therapy

 

[anonymous]

So many people to kill with cerebral hemorrhages, so little time.

 

[anonymous]

This is really staggering. That scathing report from Congress just dropped last Friday on how the FDA broke much every established protocol in the book in approving Aduhell. And this thing has potentially three patient deaths linked to its use that are still being investigated.

 

[anonymous]

I also think patients often wont understand the actual claims if semiinformed people even do??? So maybe if this is right. If we take the 25ish% reduction in rate of as true and the number, it isnt making it better. It isnt maintaining current state for 25 percent of the patients. It means at a year that you will have declined 9 months worth whereas an untreated patient declines 12 months worth. And it is all measured on a somewhat arbitrary numerical scale where it is derived from a likely clinically meaningless change (probably needs to be say 7x what it is reported per some opinions). Dont think most people understand slope in the target patient population.

 

[anonymous]

Is there any way you could rush a few doses to the White House?

 

[anonymous]

I also think patients often wont understand the actual claims if semiinformed people even do??? So maybe if this is right. If we take the 25ish% reduction in rate of as true and the number, it isnt making it better. It isnt maintaining current state for 25 percent of the patients. It means at a year that you will have declined 9 months worth whereas an untreated patient declines 12 months worth. And it is all measured on a somewhat arbitrary numerical scale where it is derived from a likely clinically meaningless change (probably needs to be say 7x what it is reported per some opinions). Dont think most people understand slope in the target patient population.

The benefit is questionable. The danger is real.

 

[anonymous]

NEVER GETTING APPROVED

 

[anonymous]

I also think patients often wont understand the actual claims if semiinformed people even do??? So maybe if this is right. If we take the 25ish% reduction in rate of as true and the number, it isnt making it better. It isnt maintaining current state for 25 percent of the patients. It means at a year that you will have declined 9 months worth whereas an untreated patient declines 12 months worth. And it is all measured on a somewhat arbitrary numerical scale where it is derived from a likely clinically meaningless change (probably needs to be say 7x what it is reported per some opinions). Dont think most people understand slope in the target patient population.

This will never be more than a niche product.

 

[anonymous]

This will never be more than a niche product.

I think that’s too kind. The only people who will use lecanemab are the same (very few) who used Aduhelm. Every question about efficacy and safety that a provider had about Aduhelm is still present with lecanemab. This drug is dead before it launched.