Jason Karlawish
speaker
1,378 appearances
5 recordings
1 series
first heard Feb 2021
last heard Dec 2023
Jason Karlawish’s voice in public audio — every appearance, attributed to the second.
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Appearances
It's great to be back, Alex and Eric.
Sorry I had to be under these circumstances.
Oh wow.
I'm a little more north, Ramsey, New Jersey, Bergen County, a little more north on the Garden State Parkway.
AGANIMAB is a drug manufactured to use the uh an antibody to target amyloid in the brain of a human.
The theory is that if you can remove uh amyloid, particularly uh oligomers, seems to be the target that that drug particularly seemed to target.
uh that that would um uh affect one of the underlying pathologies that's well associated with Alzheimer's disease dementia, namely elevated amyloid the presence of uh amyloid plaques along with of course tangles of tau protein.
It's one of a number of therapies of a similar
A b uh thi uh model um that's been tested in humans.
And this particular drug uh made it all the way to phase three.
Two identical phase three studies, engage and emerge, uh, which were halted on a futility analysis.
Uh data more data came in, more analyses were done.
One study popped out to have a p effect on drug greater than placebo, the other did not.
The rest is history, namely
Uh, the companies decided to still pursue an application to FDA.
Uh we'll talk more, but it seems like FDA was as encouraging as the company was, uh uh, if not even more.
And uh a review occurred in November of last year that Aaron was present at, I witnessed, uh, which resulted in a decision that was nearly unanimous to say the drug was not safe and effective based on standard approval regulations to decide.
Uh time passed.
And on June seventh, the FDA issued a decision that said that the drug will be approved, but they used a different set of regulations that had not been discussed prior, uh the accelerator approved regulations, and here we are today with the drug available.
There's more to say, um uh obviously about those events, but
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