Jan '23 read FDA Alzheimer’s approved drug, leca
Post# of 155042
(Total Views: 757)
Posted On: 09/02/2024 10:46:46 PM
Jan '23 read FDA Alzheimer’s approved drug, lecanemab. Forget what their patent life is, etc..
But this jan 2023 article data shows how their "fantastic", was really not soooo....uh, great.
* There was a big announcement in January from the FDA. They were accelerating approval for a drug called lecanemab.
* Now, in clinical trials, lecanemab's effects on early Alzheimer's disease were pretty small. Among the hundreds of patients who took the drug, cognitive decline slowed by about 27%. But that was enough to trigger excitement in both patients and scientists because, well, nothing else has worked that well. The drug met two endpoints, clearing amyloid plaques in the brain and slowing the rate of cognitive decline.
27% equaled ...... "triggered excitement"
_______
* It turns out that 22 of that 25% identify as Hispanic or Latino. Only 3% identified as Black or African American.
* So his point is that even though the trial results overall were statistically significant, they didn't reveal much about how the drug impacted Hispanic or Latino and Black or African American patients. And that matters because those populations are at a higher risk for Alzheimer's disease."
Yet FDA directly touted it's status.
https://www.npr.org/transcripts/1162601892
________
Expecting the same accelerated approval after wooping the dog shit out of this "triggered excitement", that is also for only....early stage.
Don't care about a direct FDA mention or not ---- just give us our fair due per policies.
Let's get it Cytodyn!!!
But this jan 2023 article data shows how their "fantastic", was really not soooo....uh, great.
* There was a big announcement in January from the FDA. They were accelerating approval for a drug called lecanemab.
* Now, in clinical trials, lecanemab's effects on early Alzheimer's disease were pretty small. Among the hundreds of patients who took the drug, cognitive decline slowed by about 27%. But that was enough to trigger excitement in both patients and scientists because, well, nothing else has worked that well. The drug met two endpoints, clearing amyloid plaques in the brain and slowing the rate of cognitive decline.
27% equaled ...... "triggered excitement"
_______
* It turns out that 22 of that 25% identify as Hispanic or Latino. Only 3% identified as Black or African American.
* So his point is that even though the trial results overall were statistically significant, they didn't reveal much about how the drug impacted Hispanic or Latino and Black or African American patients. And that matters because those populations are at a higher risk for Alzheimer's disease."
Yet FDA directly touted it's status.
https://www.npr.org/transcripts/1162601892
________
Expecting the same accelerated approval after wooping the dog shit out of this "triggered excitement", that is also for only....early stage.
Don't care about a direct FDA mention or not ---- just give us our fair due per policies.
Let's get it Cytodyn!!!
(3)
(0)