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The FDA approves an Alzheimer's drug that appears to modestly slow the disease

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The FDA has approved a new drug that appears to slow down Alzheimer's disease. NPR's Jon Hamilton reports.

JON HAMILTON, BYLINE: The new drug known as Lecanemab will be marketed under the brand name Leqembi. Maria Carrillo, chief science officer of the Alzheimer's Association, says it could help millions of people in the early stages of the disease.

MARIA CARRILLO: This is a milestone for people eligible for this treatment, for their families, for the research community. This is absolutely a game changer.

HAMILTON: Leqembi received what's known as accelerated approval based on its ability to remove the sticky substance amyloid from the brain. The FDA is likely to consider a full approval later this year. That decision will hinge on a large study published in November showing that Leqembi slowed the loss of memory and thinking by 27%. Carrillo expects the drug to get full approval.

CARRILLO: The science speaks for itself. The science is telling us that lowering amyloid is leading to clinical benefit.

HAMILTON: Leqembi will cost about $26,500 a year, according to its developers, the Japanese company Eisai and the American firm Biogen. That cost probably won't be covered by Medicare, though, until the FDA grants a full approval. Carrillo says that's unfair.

CARRILLO: Without coverage, we are talking about a breakthrough that is not available to the American public. And that is not acceptable.

HAMILTON: Leqembi is likely to fare better than its predecessor, Aduhelm, which has reached only a few hundred patients since its accelerated approval in 2021. Aduhelm also removes amyloid. But a pair of studies reached opposite conclusions about whether the drug also preserves mental function. Dr. Joy Snider, a neurologist at Washington University School of Medicine in St. Louis, says the evidence is much stronger for Leqembi.

JOY SNIDER: It's not a cure. It doesn't stop the disease completely. It doesn't make people get better. But it does slow down disease progression in very mild disease.

HAMILTON: Snider, who helped test the drug, says the benefit appears to be small but meaningful.

SNIDER: Maybe you could keep driving for an extra six months or a year. Maybe you could keep doing your checkbook for an extra six months to a year. Things like that.

HAMILTON: Leqembi can cause side effects like swelling or bleeding in the brain. But Snider says it is the first approved drug that clearly alters the course of Alzheimer's rather than just relieving symptoms.

SNIDER: I'm hopeful, I think many people are, that this is the start of a trend of many new drugs. And there are several more, you know, coming down behind it that may really help us start to develop some ways to slow down this disease.

HAMILTON: It could be many months, though, before Leqembi reaches most of the millions of patients who might benefit. To qualify for treatment, people need to undergo tests showing that they are in the early stages of dementia and that their brains contain the amyloid deposits that are a hallmark of Alzheimer's. That process is likely to include at least two visits to specialists who are in short supply. Jakub Hlavka, a health policy expert at the University of Southern California, says the result is likely to be a very long queue.

JAKUB HLAVKA: Roughly speaking, we can expect that to take about five years before all of the currently eligible patients may get cleared through that queue.

HAMILTON: Treating all these patients could cost tens of billions of dollars a year. Hlavka says the price tag is so high that payers and federal officials may consider a new approach to caring for people with dementia.

HLAVKA: One of the potential solutions would be to see if we can pool all of the dementia patients who are covered under different plans into a single risk pool, and then essentially provide coordinated access and care to those patients.

HAMILTON: There's a precedent for that approach. Since the early 1970s, Medicare has run a special program for people of all ages whose kidneys are failing.

Jon Hamilton, NPR News.

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