European Medicines Agency rejects breakthrough Alzheimer’s drug
欧洲药品管理局拒绝了突破性的阿尔茨海默病药物

The EU’s drug regulator has declined to approve a breakthrough Alzheimer’s treatment produced by drugmakers Eisai and Biogen, warning about rare brain swelling side-effects.
欧盟的药品监管机构拒绝批准由爱施尔和生物技术公司生产的突破性阿尔茨海默病治疗药物，警告罕见的脑部肿胀副作用。

A European Medicines Agency committee on Friday recommended that Leqembi should be denied a marketing authorisation in the EU, severely knocking the likelihood of approval for use in the 27-member bloc. The neurodegenerative condition affects about 50mn people worldwide.
一个欧洲药品管理局委员会在星期五建议，不应在欧盟授予 Leqembi 营销授权，严重影响了该药在 27 个成员国使用的批准可能性。这种神经退行性疾病影响全球约 5000 万人。

The move comes after the US Food and Drug Administration approved the drug for US patients last year. Thousands of Alzheimer’s patients have already received Leqembi infusions in the US, with the drug projected to generate $154mn in revenue worldwide this year, almost all from the US, according to analysts at Cantor Fitzgerald.
此举是在美国食品和药物管理局去年批准该药物用于美国患者之后采取的。据康特菲茨杰分析师称，已有数千名阿尔茨海默病患者在美国接受了 Leqembi 输液，预计该药物今年将在全球创造 1.54 亿美元的收入，几乎全部来自美国。

The EMA raised concerns about rare side-effects known as amyloid-related imaging abnormalities, or Aria, caused by the drug, noting that “some patients had serious events, including large bleeds in the brain which required hospitalisation”.
欧洲药品管理局对罕见副作用——淀粉样蛋白相关成像异常（Aria）提出了担忧，该副作用是由药物引起的，指出“一些患者发生了严重事件，包括大脑出血需要住院治疗”。

Leqembi, whose scientific name is lecanemab, is part of a new class of Alzheimer’s drugs that promise to slow the progression of the memory-robbing disease. Alzheimer’s diagnostics and treatments have become the focus of intense research efforts as knowledge of the condition’s causes improves.
勒克曼比（Leqembi）的科学名称是勒卡尼马布（lecanemab），它是一种新型阿尔茨海默病药物的一部分，承诺能够减缓这种夺取记忆的疾病的进展。随着对该病症原因的了解不断提高，阿尔茨海默病的诊断和治疗已成为密集研究的焦点。

Leqembi, similar to a rival drug from US pharmaceuticals group Eli Lilly, works by removing amyloid plaque which forms in knots on the brain in Alzheimer’s patients and is linked to progression of the disease.
Leqembi，类似于美国制药集团 Eli Lilly 的一种竞争性药物，通过清除在阿尔茨海默病患者大脑上形成的淀粉样斑块来发挥作用，这些斑块与疾病的进展有关。

But while the drug reduced cognitive decline by 27 per cent in early-stage Alzheimer’s patients compared with a placebo group in a late-stage clinical trial, it did also cause rare instances of brain swelling, which were sometimes fatal.
但是，在晚期临床试验中，与安慰剂组相比，这种药物使早期阿尔茨海默病患者的认知衰退减少了 27％，但也会引起罕见的脑肿胀，有时是致命的。

“The seriousness of this side-effect should be considered in the context of the small effect seen with the medicine,” the EMA added. “Overall, the [Committee for Medicinal Products for Human Use] considered that the benefits of treatment are not large enough to outweigh the risks associated with Leqembi.”
欧洲药品管理局补充说：“应该在药物的小效果的背景下考虑这种副作用的严重性。”“总体而言，人用药品委员会认为，治疗的好处不足以抵消与 Leqembi 相关的风险。”

Japan’s Eisai said it planned to ask the EMA committee to re-examine its decision in a bid to win approval in the EU, where 6.9mn people suffer from Alzheimer’s. Alongside the US, Leqembi has been approved in five other countries including Japan and China.
日本艾克赛计划要求 EMA 委员会重新审查其决定，以赢得在欧盟获批准的机会，欧盟有 690 万人患有阿尔茨海默病。除美国外，勒克美已在包括日本和中国在内的其他五个国家获得批准。

Lynn Kramer, Eisai’s chief clinical officer, called the decision “extremely disappointing”, adding that “there is a significant unmet need for new innovative treatment options that target an underlying cause of disease progression”.
林恩·克莱默（Lynn Kramer），艾萨伊（Eisai）首席临床官，称这一决定“令人极为失望”，并补充说“新的创新治疗选择对于针对疾病进展的潜在原因存在重大未满足需求”。

John Hardy, a neuroscience professor at University College London, predicted that the EMA decision “will be revisited as US clinicians and others gather and report real-world experience”. About two-fifths of negative rulings by the EMA medicines committee are reversed, according to Jefferies analysts.
约翰·哈迪（John Hardy）是伦敦大学学院的神经科学教授，他预测欧洲药品管理局（EMA）的决定“将在美国临床医生和其他人收集和报告实际经验后重新审视”。根据杰弗里斯分析师的说法，EMA 药品委员会做出的大约五分之二的负面裁决会被推翻。

EU sales were expected to contribute as much as $1.6bn in peak annual sales for Leqembi, which is co-produced by Eisai with Boston-based biotech Biogen. Shares in Biogen were down 5.9 per cent in early trading on Friday.
欧盟销售预计将为与总部位于波士顿的生物技术公司 Biogen 合作生产的 Leqembi 贡献高达 16 亿美元的年销售额峰值。周五早盘，Biogen 股价下跌了 5.9％。