FDA批准 Leqembi Iqlik, 在家注射阿尔茨海默氏症,经过初步四类治疗后。
FDA approves Leqembi Iqlik, an at-home injection for Alzheimer's, following initial IV treatment.
食品和药物管理局批准了Leqembi Iqlik, 这是一种亚皮型的叶卡内马布,在经过最初的18个月的静脉注射阶段后,用于阿尔茨海默氏病人每周的维持剂量。
The FDA has approved Leqembi Iqlik, a subcutaneous version of lecanemab, for weekly maintenance doses in Alzheimer's patients after an initial 18-month intravenous phase.
Eisai和Biogen研制的这种自动注射器使病人能够在家中进行治疗,从而减少了经常到诊所就诊的需要。
This autoinjector, developed by Eisai and Biogen, allows patients to administer treatment at home, reducing the need for frequent clinic visits.
新的配方保持与四类治疗类似的临床效益,同时减少系统性反应。
The new formulation maintains clinical benefits similar to IV treatment while reducing systemic reactions.
核准的依据是第3阶段试验数据,旨在改善获得治疗的机会和病人的方便。
The approval is based on phase 3 trial data and aims to improve treatment accessibility and patient convenience.