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).
周四, 英国药物和医疗保健产品监管局批准了Eisai（场外交易：ESAIY）（场外交易：ESALF）和Biogen（纳斯达克：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适用于成人患有载脂蛋白Eε4（ApoE ε4）杂合子或非携带者的轻度认知功能障碍（MCI）和轻度阿尔茨海默病（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的阿尔茨海默病药物Leqembi在欧洲药品监管机构咨询委员会中“不通过”，并指出存在严重副作用事件。
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成为第一个获得欧洲国家授权并针对早期AD（MCI和轻度AD痴呆）的治疗药物，该药物针对疾病的潜在原因进行治疗。
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.
据估计，在英国，有982,000人患有痴呆症，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."
尽管获得批准，但英国国家卫生与护理卓越研究所（NICE）在其指南草案中表示：“新的阿尔茨海默病药物Lecanemab的益处太小，无法证明其成本效益。”
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的独立委员会表示，这是英国获得许可的首个已被证明能够将疾病进展减缓4至6个月的药物。
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.
该机构表示，由于对有限的国家卫生服务（NHS）资金的使用不具有成本效益，因此不建议使用Lecanemab进行NHS治疗。
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.
草案增加了临床试验证据，表明当乐金马布加入现有治疗时，它对延缓认知衰退有着4-6个月的小而有意义的影响。
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.
由于临床试验只报告了人们服用乐金马布18个月后的结果，因此缺乏其长期效果的证据。
"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.
独立的NICE委员会表示：“乐金马布的治疗成本包括每两周在医院注射和密切监测副作用，加上它对患者的相对较小益处，使其不能被视为对纳税人的良好回报。”
Price Action: BIIB stock is down 2.01% at $202.04 at the last check on Thursday.
价格走势: BIIb股票在最后一次交易时检查下跌2.01%至202.04美元。
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