美国国家公共电台 NPR--The FDA approves an Alzheimer's drug that appears to modestly slow the disease

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

Transcript¹

LEILA FADEL, HOST:

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

JON HAMILTON, BYLINE²: 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 milestone³ for people eligible⁴ 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 coverage⁵, 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 predecessor⁶, 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 swelling⁷ 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 essentially⁸ provide coordinated⁹ access and care to those patients.

HAMILTON: There's a precedent¹⁰ 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.

(SOUNDBITE OF EAGLE EYED TIGER'S "APOTHEOSIS")

1 transcript   

n.抄本，誊本，副本，肄业证书

参考例句：

• A transcript of the tapes was presented as evidence in court.一份录音带的文字本作为证据被呈交法庭。
• They wouldn't let me have a transcript of the interview.他们拒绝给我一份采访的文字整理稿。

2 byline   

n.署名；v.署名

参考例句：

• His byline was absent as well.他的署名也不见了。
• We wish to thank the author of this article which carries no byline.我们要感谢这篇文章的那位没有署名的作者。

3 milestone   

n.里程碑；划时代的事件

参考例句：

• The film proved to be a milestone in the history of cinema.事实证明这部影片是电影史上的一个里程碑。
• I think this is a very important milestone in the relations between our two countries.我认为这是我们两国关系中一个十分重要的里程碑。

4 eligible   

adj.有条件被选中的；(尤指婚姻等)合适(意)的

参考例句：

• He is an eligible young man.他是一个合格的年轻人。
• Helen married an eligible bachelor.海伦嫁给了一个中意的单身汉。

5 coverage   

n.报导，保险范围，保险额，范围，覆盖

参考例句：

• There's little coverage of foreign news in the newspaper.报纸上几乎没有国外新闻报道。
• This is an insurance policy with extensive coverage.这是一项承保范围广泛的保险。

6 predecessor   

n.前辈，前任

参考例句：

• It will share the fate of its predecessor.它将遭受与前者同样的命运。
• The new ambassador is more mature than his predecessor.新大使比他的前任更成熟一些。

7 swelling   

n.肿胀

参考例句：

• Use ice to reduce the swelling. 用冰敷消肿。
• There is a marked swelling of the lymph nodes. 淋巴结处有明显的肿块。

8 essentially   

adv.本质上，实质上，基本上

参考例句：

• Really great men are essentially modest.真正的伟人大都很谦虚。
• She is an essentially selfish person.她本质上是个自私自利的人。

9 coordinated   

adj.协调的

参考例句：

• The sound has to be coordinated with the picture. 声音必须和画面协调一致。
• The numerous existing statutes are complicated and poorly coordinated. 目前繁多的法令既十分复杂又缺乏快调。 来自英汉非文学 - 环境法 - 环境法

10 precedent   

n.先例，前例；惯例；adj.在前的，在先的

参考例句：

• Is there a precedent for what you want me to do?你要我做的事有前例可援吗？
• This is a wonderful achievement without precedent in Chinese history.这是中国历史上亘古未有的奇绩。