欧盟批准Eli Lilly的Kisunla用于早期阿尔茨海默氏症, EU approves Eli Lilly’s Kisunla for early Alzheimer’s, targeting amyloid plaques to slow decline in mild cases.

Eli Lilly's Kisunla(donanemab)已获得欧洲委员会批准,在有轻度认知障碍或轻微痴呆的成人中治疗早期症状性阿尔茨海默症,这些成人经氨基体病理学证实,不包括具有特定遗传风险因素的成年人。 Eli Lilly’s Kisunla (donanemab) has received European Commission approval for treating early symptomatic Alzheimer’s in adults with mild cognitive impairment or mild dementia confirmed by amyloid pathology, excluding those with a specific genetic risk factor. 该药物每月给药一次，针对淀粉样斑块，并在临床试验中显示，可以在 18 个月内减缓认知和功能下降，从而可能帮助患者更长时间地保持独立性。 The drug, given monthly, targets amyloid plaques and has shown in clinical trials to slow cognitive and functional decline over 18 months, potentially helping patients maintain independence longer. 批准的依据是来自TRAILLAZER-ALZ 2和6号审判的数据,涉及多国1 700多名参与者。 Approval is based on data from the TRAILBLAZER-ALZ 2 and 6 trials involving over 1,700 participants across multiple countries. 虽然治疗可以减少向晚期疾病阶段的治疗,但是它带来诸如脑肿胀或出血等风险,而这种风险可能是严重的或危及生命的。 While the treatment may reduce progression to advanced disease stages, it carries risks like brain swelling or bleeding, which can be serious or life-threatening. 阿尔茨海默氏病影响到欧洲多达690万人,预计到2050年病例将增加一倍。 Alzheimer’s affects up to 6.9 million people in Europe, with cases expected to nearly double by 2050. 欧盟成员国将决定偿还问题,有些国家由于成本高和临床效益不确定而选择不支付药物。 EU member states will decide on reimbursement, with some countries opting not to cover the drug due to high costs and uncertain clinical benefits.