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FDA Approves A Controversial Drug To Treat Alzheimer's Disease


Yesterday, the Food and Drug Administration approved the first new drug for Alzheimer's disease in nearly 20 years, but scientists are divided on whether that was a good idea. Joining us now to talk about it, NPR science correspondent Jon Hamilton. Hi, Jon.


MARTIN: Explain this controversy.

HAMILTON: Well, this controversy is about a drug called Aduhelm. The generic name is aducanumab. And this drug has generated all kinds of excitement because it is the first approved drug that does more than just relieve the symptoms of Alzheimer's. This drug actually affects an underlying disease process by reducing the amount of sticky amyloid plaque that builds up in the brain. The catch is that removing this plaque may not actually help patients avoid memory loss and thinking problems. One big study showed that it did. Another showed that it didn't. An advisory panel voted against approval. And the FDA typically would not approve a drug under those circumstances, so there's been a lot of public debate.

MARTIN: So why did they? Why did the FDA move forward?

HAMILTON: Well, they published a pretty detailed explanation of their thinking, and it was notable for what it did not do. It never tries to argue that studies have shown that Aduhelm actually works to preserve someone's thinking or memory. Instead, it focuses on what has been shown for sure, which is that the drug can remove plaque from the brain. And they argue that a drug that can remove plaque is reasonably likely to slow down the disease, even though the studies so far have not confirmed that.

The other point the FDA made was that there is no other treatment for this disabling fatal disease that affects 6 million people in the U.S. So they said that justifies giving Aduhelm something called accelerated approval. What that means in practical terms is that the drug's maker have to conduct another study after the product is already on the market.

MARTIN: So we nodded to it above, but just say more about the reaction to the FDA's decision.

HAMILTON: Well, a lot of love, a lot of hate and not any small amount of celebration among investors who think Aduhelm is going to make a lot of money. I spoke with Dr. Richard Hodes. He's the director of the National Institute on Aging. And he did not directly question the FDA's decision, but he did suggest that drugs to remove amyloid may be kind of a dead end scientifically. So he says the NIH is, and especially his agency, is more interested in other kinds of treatment these days.

RICHARD HODES: People who work in the field look at amyloid as one component of the pathology underlying disease but not the only one. Of the NIA-supported clinical trials, it's only a minority, in fact, that are currently targeting amyloid.

HAMILTON: Another reason the NIH is looking elsewhere is that there have been large clinical trials of a couple of dozen amyloid drugs in the past 20 years or so, and until Aduhelm, they all failed to help patients.

MARTIN: So who's supporting the FDA's decision?

HAMILTON: Well, doctors who treat Alzheimer's patients - many of them have been very supportive. There's also been strong support from patient groups. I talked with Harry Johns. He's the CEO of the Alzheimer's Association, and he told me they see Aduhelm as this small first step, you know, as much like the first drugs for some other diseases.

HARRY JOHNS: Hypertension, HIV AIDS - not perfect treatments, but have stimulated other investments that then become so important to advancing the cause.

HAMILTON: Part of what he's arguing there, I should explain, is that many people think approving a drug like Aduhelm might encourage the development of other drugs, but pharmaceutical companies have become pretty wary about trying to cure Alzheimer's. So maybe not.

MARTIN: I mean, this drug is also very expensive, right? Is that part of what is concerning people?

HAMILTON: Very expensive. The drug's makers, Biogen and Eisai, say the drug alone will cost $56,000 a year. And of course, patients will have to take it for many years. Also, there are likely to be other costs 'cause it's administered in a medical setting. So it's expensive, and Medicare is going to have to really think about whether it wants to cover this treatment.

MARTIN: NPR's Jon Hamilton. Thank you so much, Jon.

HAMILTON: Thanks. Transcript provided by NPR, Copyright NPR.

Jon Hamilton is a correspondent for NPR's Science Desk. Currently he focuses on neuroscience and health risks.

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