US 認可するs Alzheimer's 麻薬 that modestly slows 病気
WASHINGTON (AP) - U.S. health 公式の／役人s on Friday 認可するd a closely watched Alzheimer´s 麻薬 that´s been shown to modestly slow the 早期に 行う／開催する／段階s of the brain-robbing 病気, albeit with 可能性のある safety 危険s that doctors and 患者s will have to carefully 重さを計る.
The 麻薬, Leqembi, is the first that´s been convincingly shown to slow the 拒絶する／低下する in memory and thinking that defines Alzheimer´s by 的ing the 病気's underlying biology. The Food and 麻薬 行政 認可するd it 特に for 患者s with 穏やかな or 早期に 事例／患者s of dementia.
Leqembi, from Japan's Eisai and its U.S. partner Biogen, is a rare success in a field accustomed to failed 実験の 治療s for the incurable 条件. The 延期する in cognitive 拒絶する／低下する brought about by the 麻薬 likely 量s to just several months, but some 専門家s say it could still meaningfully 改善する people's lives.
"This 麻薬 is not a cure. It doesn´t stop people from getting worse, but it does measurably slow the progression of the 病気," said Dr. Joy Snider, a neurologist at Washington University in St. Louis. "That might mean someone could have an extra six months to a year of 存在 able to 運動."
Snider 強調する／ストレスd that the 薬／医学, pronounced "leh-KEM-bee," comes with downsides, 含むing the need for twice-a-month infusions and possible 味方する 影響s like brain swelling and bleeding.
是認 （機の）カム 経由で FDA's 加速するd pathway, which 許すs 麻薬s to 開始する，打ち上げる based on 早期に results, before they're 確認するd to 利益 患者s. The 機関's use of that shortcut has come under 増加するing scrutiny from 政府 監視者s and congress ional 捜査官／調査官s.
This Dec. 21, 2022 image 供給するd by Eisai in January 2023, shows vials and 一括ing for their 医薬 Leqembi. On Friday, Jan. 6, 2023, U.S. health 公式の／役人s 認可するd Leqembi, a new Alzheimer's 麻薬 that modestly slows the brain-robbing 病気. The Food and 麻薬 行政 認めるd the 是認 Friday for 患者s in the 早期に 行う／開催する／段階s of Alzheimer's. (Eisai 経由で AP)
Last week, a congressional 報告（する）／憶測 設立する that FDA's 是認 of a 類似の Alzheimer's 麻薬 called Aduhelm - also from Biogen and Eisai - was "rife with 不正行為s," 含むing a number of 会合s with 麻薬 company スタッフの一員s that went undocumented.
Scrutiny of the new 麻薬, known chemically as lecanemab, will likely mean most 患者s won´t start receiving it for months, as 保険会社s decide whether to cover it and for whom.
The 麻薬 will cost $26,500 for a typical year´s 価値（がある） of 治療. Eisai said that price 反映するs the 麻薬´s 利益 ーに関して／ーの点でs of 改善するd 質 of life, 減ずるd 重荷（を負わせる）s for caregivers and other factors. The company pegged its 全体にわたる value at $37,000 per year, but said it 定価つきの the 麻薬 lower to 減ずる costs for 患者s and 保険会社s. An 独立した・無所属 group that 査定する／（税金などを）課すs 麻薬 value recently said the 麻薬 would have to be 定価つきの below $20,600 to be cost-効果的な.
Some 6 million people in the U.S. and many more 世界的な have Alzheimer´s, which 徐々に attacks areas of the brain needed for memory, 推論する／理由ing, communication and daily 仕事s.
The FDA's 是認 was based on one 中央の-行う／開催する／段階 熟考する／考慮する in 850 people with 早期に symptoms of Alzheimer's who also 実験（する）d 肯定的な for a type of brain plaque that is a hallmark of the 病気.
Since then, Eisai has published the results of a larger 1,800-患者 熟考する／考慮する that the FDA is 推定する／予想するd to soon review to 確認する the 麻薬's 利益, setting up a 決定／判定勝ち（する） on 十分な 是認 later this year.
The larger 熟考する／考慮する 跡をつけるd 患者s´ results on an 18-point 規模 that 対策 memory, judg ment and other cognitive abilities. Doctors 収集する the 率ing from interviews with the 患者 and a の近くに 接触する. After 18 months, 患者s receiving Leqembi 拒絶する／低下するd more slowly - a difference of いっそう少なく than half a point on the 規模 - than 患者s who received a 模造の infusion. The 延期する 量d to just over five months.
There is little 合意 on whether that difference translates into real 利益s for 患者s, such as greater independence.
"Most 患者s won´t notice the difference," said Dr. Matthew Schrag, a neurology 研究員 at Vanderbilt University. "This is really やめる a small 影響 and probably below the threshold of what we´d call clinically 重要な."
Schrag and some other 研究員s believe a meaningful 改良 would 要求する at least a difference of one 十分な point on the 18-point 規模.
Leqembi 作品 by （疑いを）晴らすing a sticky brain protein called amyloid that´s a 重要な 指示する人（物） of Alzheimer´s. But it´s not （疑いを）晴らす 正確に／まさに what 原因（となる）s the 病気. A string of other amyloid-的ing 麻薬s have failed and many 研究員s now think combination 治療s will be needed.
Aduhelm, the 類似の 麻薬, was marred by 論争 over its 有効性.
The FDA 認可するd that 麻薬 in 2021 against the advice of the 機関's own outside 専門家s. Doctors hesitated to 定める／命ずる the 麻薬 and 保険会社s 制限するd ニュース報道.
The FDA did not 協議する the same 専門家 パネル盤 before 認可するing Leqembi.
Rep. Rosa DeLauro of Connecticut - a frequen t FDA critic - said in a 声明 Friday that she was "深く，強烈に 関心d that FDA chose to forego" a パネル盤 会合 on the 麻薬.
Schrag said many of the same 関心s 適用する to both 麻薬s.
"Is this slight, measurable 利益 価値（がある） the hefty price tag and the 味方する 影響s 患者s may experience?" he asked. "I have pretty serious 疑問s."
About 13% of 患者s in Eisai´s 熟考する／考慮する had swelling of the brain and 17% had small brain bleeds, 味方する 影響s seen with earlier amyloid-的ing 医薬s. In most 事例／患者s those problems didn´t 原因（となる） symptoms, which can 含む dizziness and 見通し problems.
Also, several Leqembi 使用者s died while taking the 麻薬, 含むing two who were on 血-thinning 医薬s. Eisai has said the deaths can´t be せいにするd to the 麻薬. The FDA label 警告するs doctors to use 警告を与える if they 定める／命ずる Leqembi to 患者s on 血 thinners.
保険会社s are likely to only cover the 麻薬 for people like those in the company 熟考する／考慮する - 患者s with 穏やかな dementia and 確定／確認 of amyloid 増強. That typically 要求するs expensive brain ざっと目を通すs or a spinal fluid 実験（する）. Doctors will need to 成し遂げる a different type of ざっと目を通す to periodically check for brain swelling and bleeding.
A 重要な question in the 麻薬´s rollout will be 保険 ニュース報道 by Medicare, the 連邦の health 計画（する） that covers 60 million 上級のs and other Americans. The 機関 厳しく 制限するd ニュース報道 of Aduhelm, essentially wiping out its U.S. market and 誘発するing Biogen to abandon marketing 計画（する）s for the 麻薬.
Eisai (n)役員／(a)執行力のあるs said they have already spent months discussing their 麻薬's data with Medicare 公式の／役人s. ニュース報道 isn't 推定する／予想するd until after the FDA 確認するs the 麻薬's 利益, 推定する／予想するd later this year.
"Once we have a Medicare 決定／判定勝ち（する）, then we can truly 開始する，打ち上げる the 麻薬 across the country," said Eisai's U.S. CEO, Ivan Cheung.
Betsy Groves, 73, was 診断するd with Alzheimer´s in 2021. A former lecturer at Harvard´s 卒業生（する） school of education, she noticed she was having trouble remembering some student 指名するs and answering questions.
Her 初期の diagnosis, based on a cognitive examination, was later 確認するd by a 肯定的な 実験（する） for amyloid.
Groves, of Cambridge, Massachusetts, says she is "more than willing" to try Leqembi, にもかかわらず 可能性のある 味方する 影響s and the need for infusions.
"For me, the minute that 麻薬 comes on the market - and I get my doctor´s 是認 - I´m going to take it," Groves said.
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AP 医療の Writer Lauran Neergaard 与える／捧げるd to this 報告（する）／憶測
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The Associated 圧力（をかける） Health and Science Department receives support from the Howard Hughes 医療の 学校／設ける´s Science and 教育の マスコミ Group. The AP is 単独で 責任がある all content.
FILE - This Oct. 7, 2003 とじ込み／提出する photo shows a closeup of a human brain 影響する／感情d by Alzheimer's 病気, on 陳列する，発揮する at the Museum of Neuroanatomy at the University at Buffalo in Buffalo, N.Y. On Friday, Jan. 6, 2023, U.S. health 公式の／役人s 認可するd Leqembi, a new Alzheimer's 麻薬 that modestly slows the brain-robbing 病気. The Food and 麻薬 行政 認めるd the 是認 Friday for 患者s in the 早期に 行う／開催する／段階s of Alzheimer's. (AP Photo/David Duprey)
