Aducanumab

But if FDA ends up approving that particular application despite the no vote, I still think they'll have built a record from that particular meeting that they're doing something that's still consistent with the advice they got.

That's, I would say, a contrast with the Aduhelm meeting, where I think the committee members were as clear as they could be that they did not think the product should be approved.

So, you know, again, I think that's part of how the process plays out and the advantages of doing it and engaging with the committee, engaging with the community, having it play out live and in public rather than through memos written after the fact just seems like a better process all around.

How much has, do you think, has the approach of HHS to, say, ACIP factored into this? I know we saw the, I think it was the Pharmacy Compounding Advisor Committee, you know, when they went through the peptides stuff, it looked kind of, there were questions being asked about that one.

You can say, oh, okay, well, we can look at the progression of disease based on this marker, right? So

the classic case is Aduhelm and amyloid beta, right? So meant to treat, it was Alzheimer's, I think, not ALS.

And amyloid beta was kind of the leading hypothesis in the field that they, I don't know, you'd have a better chance medical vocabulary to describe, but this was a amyloid beta as a surrogate endpoint for Alzheimer's.

So the Adoham was basically a drug that got approved in an advisory committee, staff was overruled.

It was fortunately later pulled from the market or something like that.

But I think that led to, wasn't it?

I think Aduhelm is still on the market.

Yeah, I think it's still on the market.

Um, in 2019, there were $350 million increase for Alzheimer's and dementia research.

And then in 2021, there is a medication, and I always mispronounce them, and I'm so sorry, so talk to your doctor about this, but it's Aduhelm, um, and it received accelerated approval from the FDA, and that's the very first approved drug to treat Alzheimer's.

It's addressing the underlying biology of the disease.

Mm-hmm.

What's crazy is that I think there was, like, six or seven drug companies, and they were all trying to find this an- antibody or some cure for this, uh, beta amyloid, and nobody ever found it.

I think Biogen, uh, sank $18 billion into looking for this, this drug on this one immunotherapy, Aduhelm, and they were sure that that was gonna do it.

They submitted it to FDA twice, and they turned them down in 2019.

That tells me if you have five drug companies that have been looking at it for 20 years for, uh, something that will, will stop beta amyloid and nothing has ever worked.

I, and I, and, and I, I was smiling from ear to ear.

The drug, called Aducanumab, was what everyone had been hoping for.

The results sent share prices in the pharmaceutical company, Biogen, rocketing.

The trial showed that the drug was having a remarkable impact on the brains of people with Alzheimer's.