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Eli Lilly's Alzheimer's Drug Raises Hopes but Faces Regulatory Hurdles in Europe

Eli Lilly's Alzheimer's Drug Raises Hopes but Faces Regulatory Hurdles in Europe

伊莉莉的阿爾茨海默病藥物引發希望,但在歐洲面臨監管障礙
Benzinga ·  01:51

On Monday, Eli Lilly And Co (NYSE:LLY) announced plans to boost its presence in the U.K., following a collaboration with the U.K. government that was revealed at the International Investment Summit.

禮來(NYSE:LLY)週一宣佈計劃加強其在英國的存在,此前與英國政府合作,在國際投資峯會上披露。

The global pharmaceutical giant is set to invest in a new Gateway Lab in the U.K., building on the country's leading life sciences sector. This 279 million pounds ($294.41 million) investment will tackle significant health challenges and further solidify the U.K.'s reputation as a world leader in healthcare innovation.

全球藥品巨頭計劃在英國投資新的Gateway Lab,以發展該國領先的生命科學領域。這項2,7900萬英鎊(29441萬美元)的投資將應對重大健康挑戰,並進一步鞏固英國作爲全球醫療創新領域的世界領導者的聲譽。

The life sciences sector is already worth 108 billion pounds to the U.K. economy, and the partnership with Lilly demonstrates its ongoing value in advancing public health.

生命科學領域已經爲英國經濟創造了1080億英鎊的價值,與禮來的合作展示了其在推動公共衛生方面持續發揮的價值。

With the planned Gateway Lab marking the first such facility in Europe, the U.K. is positioning itself at the forefront of global scientific progress.

計劃中的Gateway Lab將成爲歐洲首個這樣的設施,英國正在將自己定位在全球科學進步的最前沿。

Amid the excitement around new investments, scrutiny continues over Lilly's Alzheimer's drug, donanemab.

在新投資帶來的興奮氛圍中,人們繼續關注禮來的阿爾茨海默病藥物多納替單抗。

David Ricks, CEO of Eli Lilly, has touted the drug's potential as a groundbreaking treatment that could prevent Alzheimer's by addressing the buildup of amyloid plaques in the brain.

禮來首席執行官大衛·裏克斯稱讚這種藥物的潛力,認爲它是一種具有突破性的治療方法,可以通過解決大腦中澱粉樣斑塊堆積問題來預防阿爾茨海默病。

In a meeting with former U.K. Health Secretary Victoria Atkins in December 2023, Ricks described donanemab as a "one-and-done" treatment that could stop Alzheimer's before symptoms appear. However, data supporting this claim remain limited, and the drug is still undergoing trials, with results not expected until 2027.

在2023年12月與前英國衛生大臣維多利亞·阿特金斯會面時,裏克斯將多納替單抗描述爲一種「一勞永逸」的治療方法,可以在症狀出現之前阻止阿爾茨海默病。然而,支持該說法的數據仍然有限,該藥物仍在進行試驗,預計結果將在2027年出來。

European regulators have been more cautious than their U.S. counterparts regarding new Alzheimer's treatments like donanemab and lecanemab. The European Medicines Agency (EMA) has already rejected Eisai Co., Ltd (OTC:ESALY) and Biogen Inc.'s (NASDAQ:BIIB) lecanemab due to safety concerns, specifically related to amyloid-related imaging abnormalities (Aria), such as brain swelling and bleeding.

歐洲監管機構在新的阿爾茨海默病治療方法上比美國同行更爲謹慎,如多納替單抗和勒卡替單抗。歐洲藥品管理局(EMA)已經因安全擔憂,特別是與腦部腫脹和出血等澱粉樣相關成像異常(Aria)有關,拒絕了大塚製藥(OTC:ESALY)和生物新領域有限公司(納斯達克:BIIB)的勒卡替單抗。

Over a third of donanemab patients experienced Aria during clinical trials, raising similar concerns.

在丹納麥治療患者中有超過三分之一的人在臨床試驗中出現了Aria,引起了類似的擔憂。

While the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) is currently reviewing donanemab, it has already approved lecanemab, though the National Institute for Health and Care Excellence (NICE) ruled the drug too costly for NHS prescriptions.

儘管英國藥品和醫療產品監管局(MHRA)目前正在審查丹納麥,但已經批准了萊卡麥,儘管英國國家衛生與護理卓越研究所(NICE)裁定該藥對NHS處方來說成本過高。

The challenges in adopting these new treatments also stem from the complexity and cost of diagnosing Alzheimer's early enough for the drugs to be effective, the Financial Times highlighted.

採用這些新治療方法面臨的挑戰也源於早期診斷阿爾茨海默病的複雜性和成本,金融時報強調了這一點。

Expensive PET scans are required to identify eligible patients, and there are concerns over the limited availability of PET cameras in the U.K.

需要昂貴的PEt掃描來識別符合條件的患者,而英國的PEt攝像機的有限供應也引起擔憂。

Price Action: LLY stock is trading 0.07% lower at $931.40 at last check Monday.

股價走勢:禮來股價最近交易下跌0.07%,報931.40美元。

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Photo by Jonathan Weiss via Shutterstock

由Jonathan Weiss拍攝,通過shutterstock提供的照片

譯文內容由第三人軟體翻譯。


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