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FDA ‘shifting the bar’ for approval with new Alzheimer’s drug: Eli Lilly CEO

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Eli Lilly CEO David Ricks joins 'Influencers with Andy Serwer' to discuss the FDA's approval of Biogen's new Alzheimer’s drug.

Video Transcript

ANDY SERWER: In the news this week is the FDA'S approval of Biogen's Alzheimer's drug. What's your reaction to that? And I want to talk about your efforts in that area as well. But what do you-- what's your take, David?

DAVID RICKS: Well, to be honest, Andy, we're still kind of processing what occurred. I think it was surprising for a lot of people, for a few reasons. One, the data set itself was pretty controversial. This happens in medical research, where the gold standard for approval is you pick your-- you call your shot and then you hit your shot, like Babe Ruth pointing at the left field and then hitting his home run there. That's what is sort of the on target, normal, what we call phase three or late stage success that leads to FDA approvals.

Here, something different happened. And this happens pretty frequently in medical development, where they call their shot and then they ended up stopping the study and then looking back and seeing something more encouraging and then work with the agency to get an approval. That's not a normal process. And having worked ourselves in Alzheimer's for the last 34 years, and we've had lots of failures too, and on look back sometimes you become encouraged. But really it's important that I think drug companies generate very solid evidence for the use of our products.

So we're processing this. Because to approve this, the FDA actually, in the end, did not say that those results were solid evidence. What they said was that the drug moves what's known as a biomarker, or a precursor to the disease, in a very meaningful way, which I think is without dispute. But then said that that biomarker or precursor is enough for approval, so in a way, sort of shifting the bar or the policy for Alzheimer's approvals.

I think this does a few things. One-- well, there'll be lots of discussion about Biogen's approval and Alzheimer's. We know there's huge unmet need. So in some sense, that's a hope for patients. I think it will also unleash a lot of investment from companies to prove the same thing with other drugs, because it is a easier task. And then researchers, I think, and Lilly, and others, are worried that, OK, well, we'll be able to prove the ultimate benefit, which is slowing the disease, prevention of death and other serious medical consequences, with all these products on the market. And that's something we're working through now.

ANDY SERWER: Your stock jumped on the news. Can you talk to us about what that means for your Alzheimer's drug, and what's the status of that and how it's different from Biogen's?

DAVID RICKS: Well, maybe now looking prescient, but last summer we made a decision to initiate a confirmatory study. We have a product called Donanemab. It works in a similar way to Biogen's, although we think a little faster, little deeper clearance of plaques. We had a phase two, a middle phase study going.

And before that even concluded, we started a confirmatory study at risk, worried that the FDA would approve Biogen's drug and it would then be hard to recruit patients into a study. Because in a study, you're randomized to placebo or drug, whereas if there's a drug on the market, you can just get the drug. And so it is more difficult to find subjects for studies when there's an approved drug.

So we had accelerated that. That's well underway. It's not finished recruiting but getting close. We're glad we did that now. In the meantime, we read out the phase two results, this middle-sized study, which were very positive. We slowed cognition decay. We slowed functional decay. And we made a big difference in this biomarker, this precursor protein of the amyloid plaques.

So we're strongly encouraged. I think that's why the investors were excited on this news for Lilly. We still have a lot to prove, though. And one thing that's, to be clear, is we are deeply committed to prove the ultimate value of the therapy, which isn't to reduce some protein in people's brains that they haven't heard of. It's to affect their lives, right, to slow the decay that seniors experience with Alzheimer's. We aim to prove that. And this study, which we started last summer, should conclude in '23. So that seems like a long way away, but in drug development time it's pretty short. But we'll have the answer, whether Donanemab slows Alzheimer's. And that's something we're very much looking forward to.