Biogen/Eisai's Alzheimer's Drug Leqembi Gets 'No Go' From European Drug Regulator's Advisory Panel, Cites Serious Side Events
Biogen/Eisai's Alzheimer's Drug Leqembi Gets 'No Go' From European Drug Regulator's Advisory Panel, Cites Serious Side Events
On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on the approval of Eisai Co., Ltd (OTC:ESALY) (OTC:ESALF) and Biogen Inc.'s (NASDAQ:BIIB) lecanemab.
周五，欧洲药品管理局（EMA）人用药品委员会（CHMP）对艾克赛科（OTC:ESALY）（OTC:ESALF）和渤健公司（纳斯达克:BIIB）的乐卡那莫（Lecanemab）的批准发表了否定意见。
The companies seek approval for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody as a treatment for early AD (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD).
两家公司正在申请这种人源抗可溶性聚集的淀粉样蛋白-β（Aβ）单克隆抗体作为早期AD（由于阿尔茨海默病（AD）引起的轻度认知障碍（MCI）和轻度AD）的治疗。
The committee considered that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine, in particular, the frequent occurrence of amyloid-related imaging abnormalities involving swelling and potential bleedings in the brain of patients who received Leqembi.
委员会认为，Lecemabi对延缓认知衰退的观察效应无法抵消与药品相关的严重副作用的风险，特别是患者接受Lecemabi后与淀粉样脑成像异常，包括肿胀和潜在的出血有关的频繁发生。
Also Read: Biogen's Leqembi Commercial Ramp-Up Modest But Up Ticking, Reports Mixed Bag Q1 Earnings.
另外阅读：渤健的Lecemabi商业转型，现报混合Q1收入数据。
In March, Biogen and Eisai faced a regulatory setback when Oral Explanation slated for March 19 at the CHMP was postponed.
3月，渤健和艾兹赛在欧洲药品管理局（CHMP）预定于3月19日的口头解释被推迟时遭遇了监管挫败。
In June, the FDA's advisory committee delivered a favorable verdict on the Eli Lilly And Co's (NYSE:LLY) Alzheimer's treatment donanemab, declaring its benefits to surpass the associated risks.
6月，美国FDA的咨询委员会对礼来公司（LLY：纽交所）的阿尔茨海默病治疗donanemab做出了一个有利的裁定，宣布其益处超过相关风险。
"We are extremely disappointed by the CHMP's negative opinion and understand that this may also be disappointing for the wider Alzheimer's disease community," said Lynn Kramer, Chief Clinical Officer at Eisai.
艾兹赛首席临床官Lynn Kramer表示：“我们对CHMP的负面意见感到极为失望，并理解这可能对更广泛的阿尔茨海默病社区也是令人失望的。”
Eisai will seek re-examination of the CHMP opinion and work with the relevant authorities to ensure this treatment is available for eligible people living with early AD in the European Union (EU) as soon as possible.
艾兹赛将寻求重新审查CHMP意见，并与有关部门合作，确保这种治疗可尽快面向欧盟适格的早期AD患者。
Lecanemab has already been approved in the United States, Japan, China, South Korea, Hong Kong, and Israel, and it is being marketed in the U.S. (as Leqembi), Japan, and China.
乐卡那莫已经获得美国、日本、中国、韩国、香港和以色列的批准，并在美国（作为Leqembi）、日本和中国销售。
AD currently affects 6.9 million people in Europe, which is expected to nearly double by 2050 as aging populations increase.
目前，AD在欧洲影响着690万人，预计随着人口老龄化的增加到2050年几乎翻倍。
Eisai serves as the lead for lecanemab's development and regulatory submissions globally. Both Eisai and Biogen co-commercialize and co-promote the product, and Eisai has final decision-making authority.
艾兹赛是乐卡那莫全球开发和监管提交的负责人。两家公司共同交叉销售和推广该产品，艾兹赛拥有最终的决策权。
Price Action: BIIB stock is down 6.11% at $213.55 at the last check on Friday.
BIIB股票最后交易价格为213.55美元，下跌6.11％。
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Photo via Shutterstock
图片来自shutterstock。