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
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.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, 英國藥物和醫療保健產品監管局批准了Eisai（場外交易：ESAIY）（場外交易：ESALF）和Biogen（納斯達克：BIIB）的Leqembi（lecanemab）.
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適用於成人患有載脂蛋白Eε4（ApoE ε4）雜合子或非攜帶者的輕度認知功能障礙（MCI）和輕度阿爾茨海默病（AD）患者。
Also Read: Biogen/Eisai's Alzheimer's Drug Leqembi Gets 'No Go' From European Drug Regulator's Advisory Panel, Cites Serious Side Events.
此外: Biogen/Eisai的阿爾茨海默病藥物Leqembi在歐洲藥品監管機構諮詢委員會中「不通過」，並指出存在嚴重副作用事件。
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成爲第一個獲得歐洲國家授權並針對早期AD（MCI和輕度AD癡呆）的治療藥物，該藥物針對疾病的潛在原因進行治療。
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，但英國國家衛生與護理卓越研究所（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，這是英國獲得許可的首個已被證明能夠將疾病進展減緩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，由於對有限的國家衛生服務（NHS）資金的使用不具有成本效益，因此不建議使用Lecanemab進行NHS治療。
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.
草案增加了臨床試驗證據，表明當樂金馬布加入現有治療時，它對延緩認知衰退有着4-6個月的小而有意義的影響。
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.
由於臨床試驗只報告了人們服用樂金馬布18個月後的結果，因此缺乏其長期效果的證據。
"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：「樂金馬布的治療成本包括每兩週在醫院注射和密切監測副作用，加上它對患者的相對較小益處，使其不能被視爲對納稅人的良好回報。」
Price Action: BIIB stock is down 2.01% at $202.04 at the last check on Thursday.
價格走勢: BIIb股票在最後一次交易時檢查下跌2.01%至202.04美元。
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圖片來自shutterstock。