FDA考虑在2026年5月24日前批准在家中使用Leqembi自动注射器来早期阿尔茨海默氏症。 FDA considers approval for at-home Leqembi autoinjector for early Alzheimer’s by May 24, 2026.

美国食品和药物管理局已对Leqembi Iqlik (lecanemab- irmb) 皮下自动注射器作为早期阿尔茨海默病,包括轻度认知障碍或轻度痴呆症的每周起始剂量的补充申请进行优先审查. The FDA has granted Priority Review to a supplemental application for Leqembi Iqlik (lecanemab-irmb) subcutaneous autoinjector as a weekly starting dose for early Alzheimer’s disease, including mild cognitive impairment or mild dementia. 如果到2026年5月24日得到批准,这将是第一次允许在家中自行管理启动和维持治疗的抗氨基胺疗法。 If approved by May 24, 2026, it would be the first anti-amyloid therapy allowing at-home self-administration for both initiation and maintenance treatment. 拟议的500毫克每周剂量为2,250毫克注射,其效力和安全性与目前的双周四注入量相当,只有不到2%的人经历过注射相关反应。 The proposed 500 mg weekly dose involves two 250 mg injections and shows comparable efficacy and safety to current bi-weekly IV infusions, with less than 2% experiencing injection-related reactions. 皮下置换选项可能缓解医疗系统需求并改善可及性。 The subcutaneous option could ease healthcare system demands and improve access.