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.
週五，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）對艾克賽科（OTC:ESALY）（OTC:ESALF）和渤健公司（納斯達克:BIIB）的樂卡那莫（Lecanemab）的批准發表了否定意見。
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).
兩家公司正在申請這種人源抗可溶性聚集的澱粉樣蛋白-β（Aβ）單克隆抗體作爲早期AD（由於阿爾茨海默病（AD）引起的輕度認知障礙（MCI）和輕度AD）的治療。
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.
委員會認爲，Lecemabi對延緩認知衰退的觀察效應無法抵消與藥品相關的嚴重副作用的風險，特別是患者接受Lecemabi後與澱粉樣腦成像異常，包括腫脹和潛在的出血有關的頻繁發生。
Also Read: Biogen's Leqembi Commercial Ramp-Up Modest But Up Ticking, Reports Mixed Bag Q1 Earnings.
另外閱讀：渤健的Lecemabi商業轉型，現報混合Q1收入數據。
In March, Biogen and Eisai faced a regulatory setback when Oral Explanation slated for March 19 at the CHMP was postponed.
3月，渤健和艾茲賽在歐洲藥品管理局（CHMP）預定於3月19日的口頭解釋被推遲時遭遇了監管挫敗。
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，美國FDA的諮詢委員會對禮來公司（LLY：紐交所）的阿爾茨海默病治療donanemab做出了一個有利的裁定，宣佈其益處超過相關風險。
"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.
艾茲賽首席臨床官Lynn Kramer表示：“我們對CHMP的負面意見感到極爲失望，並理解這可能對更廣泛的阿爾茨海默病社區也是令人失望的。”
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.
艾茲賽將尋求重新審查CHMP意見，並與有關部門合作，確保這種治療可儘快面向歐盟適格的早期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.
樂卡那莫已經獲得美國、日本、中國、韓國、香港和以色列的批准，並在美國（作爲Leqembi）、日本和中國銷售。
AD currently affects 6.9 million people in Europe, which is expected to nearly double by 2050 as aging populations increase.
目前，AD在歐洲影響着690萬人，預計隨着人口老齡化的增加到2050年幾乎翻倍。
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.
艾茲賽是樂卡那莫全球開發和監管提交的負責人。兩家公司共同交叉銷售和推廣該產品，艾茲賽擁有最終的決策權。
Price Action: BIIB stock is down 6.11% at $213.55 at the last check on Friday.
BIIB股票最後交易價格爲213.55美元，下跌6.11％。
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Photo via Shutterstock
圖片來自shutterstock。
譯文內容由第三人軟體翻譯。