Biogen's Alzheimer's Drug Secures UK Approval, But An Independent Agency Does Not Recommend Reimbursement
Biogen's Alzheimer's Drug Secures UK Approval, But An Independent Agency Does Not Recommend Reimbursement
Thursday, the U.K.'s Medicines and Healthcare products Regulatory Agency approved Eisai Co., Ltd (OTC:ESAIY) (OTC:ESALF) and Biogen Inc's (NASDAQ:BIIB) Leqembi (lecanemab).
週四，英國藥品和醫療產品監督管理局批准了愛愛富股份有限公司（場外交易：ESAIY）（場外交易：ESALF）和渤健公司（納斯達克：BIIB）的Leqembi（lecaneab）。
Lecanemab is indicated for mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.
Lecanemab適用於載脂蛋白E ε4（ApoE ε4）雜合子或非攜帶者的成年患者，其適應症爲輕度認知障礙（MCI）和由阿爾茨海默病（AD）引起的輕度癡呆。
Also Read: Biogen/Eisai's Alzheimer's Drug Leqembi Gets 'No Go' From European Drug Regulator's Advisory Panel, Cites Serious Side Events.
另請閱讀： 渤健公司/愛愛富的阿爾茨海默病藥物Leqembi被歐洲藥品監管機構諮詢小組"否決"，指出嚴重的副作用事件。
Lecanemab becomes the first treatment for early AD (MCI and mild dementia due to AD) that targets an underlying cause of the disease to be authorized in a European country.
Lecanemab成爲早期阿爾茨海默病（MCI和由AD引起的輕度癡呆）的首個針對疾病潛在原因的治療獲得歐洲國家授權。
In the United Kingdom, it is estimated that 982,000 people are living with dementia, and AD is the cause in 60-70% of people with dementia.
據估計，在英國，有982,000人患有癡呆症，其中60-70%的患有癡呆症的人患有AD。
Despite the approval, the National Institute for Health and Care Excellence (NICE), in its guidance draft, said, " benefits of the new Alzheimer's drug lecanemab are too small to justify the costs."
儘管獲得批准，但英國國家衛生與醫療卓越研究所（NICE）在其指南草案中表示：「新的阿爾茨海默病藥物lecanemab的益處太小，無法證明其成本效益。」
NICE's independent committee heard that it is the first medicine to be licensed in the UK that has been shown to slow down the progression of the disease by between 4 and 6 months.
NICE的獨立委員會表示，這是英國批准上市的首個已被證明可以將疾病進展減緩4至6個月的藥物。
The agency said it is not recommending lecanemab for use on the NHS because it is not a cost-effective use of limited NHS funding.
該機構表示，由於不是對有限的NHS資金的成本效益使用，因此不建議使用lecanemab。
The draft added the clinical trial evidence lecanemab has a small but meaningful 4-6 months effect on delaying cognitive decline when added to existing treatment.
該草案補充了麗澤那單抗的臨床試驗證據，表明該藥在現有治療基礎上延緩認知衰退方面有4-6個月的小而有意義的效果。
Because the clinical trial only reported outcomes when people had been taking lecanemab for 18 months, there is a lack of evidence on its long-term effects.
因爲臨床試驗只報告了人們服用麗澤那單抗18個月後的結果，所以缺乏關於其長期效果的證據。
"The costs of providing the treatment, including fortnightly infusions in hospital and intensive monitoring for side effects, combined with the relatively small benefits it provides to patients means it cannot be considered good value for the taxpayer," the independent NICE committee has said.
獨立的NICE委員會表示：「提供這種治療的成本，包括每兩週在醫院進行的輸液治療和對副作用進行的密切監測，再加上對患者帶來的相對較小的益處，意味着無法將其視爲對納稅人的良好價值。」
Price Action: BIIB stock is down 2.01% at $202.04 at the last check on Thursday.
股票價格走勢：BIIb股在週四最新交易時下跌2.01%，至202.04美元。
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圖片來自shutterstock。
譯文內容由第三人軟體翻譯。