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）對衛材有限公司（場外交易代碼：ESALY）（場外交易代碼：ESALF）和百健公司的批准通過了否定意見。”s（納斯達克股票代碼：BIIB）lecanemab。
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).
兩家公司尋求批准人源化抗溶性聚合β澱粉樣蛋白（Aβ）單克隆抗體，用於治療早期AD（阿爾茨海默氏病（AD）引起的輕度認知障礙和輕度AD）。
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.
該委員會認爲，觀察到的Leqembi延緩認知能力下降的作用並不能抵消與該藥物相關的嚴重副事件的風險，特別是經常出現澱粉樣蛋白相關影像異常，涉及接受Leqembi的患者腦部腫脹和潛在出血。
Also Read: Biogen's Leqembi Commercial Ramp-Up Modest But Up Ticking, Reports Mixed Bag Q1 Earnings.
另請閱讀：百健公佈的第一季度收益好壞參半，Leqembi的商業增長幅度不大，但仍在上漲。
In March, Biogen and Eisai faced a regulatory setback when Oral Explanation slated for March 19 at the CHMP was postponed.
3月，原定於3月19日在CHMP舉行的口頭解釋被推遲，Biogen和衛材面臨監管挫折。
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，美國食品藥品管理局諮詢委員會對禮來公司（紐約證券交易所代碼：LLY）的阿爾茨海默氏症治療藥物donanemab作出了有利的裁決，宣佈其益處可以超過相關風險。
"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.
衛材首席臨床官林恩·克萊默表示：“我們對CHMP的負面看法感到非常失望，也知道這也可能讓更廣泛的阿爾茨海默氏病界感到失望。”
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.
衛材將尋求重新審查CHMP的意見，並與有關當局合作，確保歐盟（EU）符合條件的早期AD患者能夠儘快獲得這種治療。
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.
Lecanemab已經在美國、日本、中國、韓國、香港和以色列獲得批准，並正在美國（名爲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.
AD目前影響歐洲的690萬人，隨着人口老齡化的增加，到2050年，這一數字預計將增加近一倍。
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.
衛材在全球範圍內負責lecanemab的開發和監管申報。衛材和百健共同商業化並共同推廣該產品，衛材擁有最終決策權。
Price Action: BIIB stock is down 6.11% at $213.55 at the last check on Friday.
價格走勢：在週五的最後一次支票中，BiIB股價下跌6.11％，至213.55美元。
- Sage, Biogen Shelve Development Of Nervous System Disorder Drug After Data Disappoints.
- 數據令人失望之後，Sage、Biogen擱置了神經系統疾病藥物的開發。
Photo via Shutterstock
照片來自 Shutterstock