Reported Earlier, Eisai And Submit LEQEMBI BLA For Subcutaneous Alzheimer's Treatment To FDA, Targeting Early Disease Stages
Reported Earlier, Eisai And Submit LEQEMBI BLA For Subcutaneous Alzheimer's Treatment To FDA, Targeting Early Disease Stages
The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If approved by the FDA, the LEQEMBI autoinjector could be used to administer LEQEMBI at home or at medical facilities, and the injection process is expected on average to take about 15 seconds. As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under review, patients who have completed the biweekly intravenous (IV) initiation phase would receive weekly doses that maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils* which can continue to cause neuronal injury even after the amyloid-beta (Aβ) plaque has been cleared from the brain.
基於Clarity AD（研究301）開放標籤延長（OLE）的數據和觀察數據建模，LEQEMBI注射器如果獲得FDA批准，將可供患者在家中或醫療機構使用，注射過程預計平均耗時約15秒。作爲皮下注射器360毫克每週維護療程的一部分，已完成兩週靜脈注射（IV）引導階段的患者會接受維持有效藥物濃度以繼續清除可能導致神經損傷的高毒性原纖維蛋白體的每週劑量，即使澱粉樣蛋白-β（Aβ）斑塊已經從大腦中清除，這些原纖維體依然可能持續引起神經損傷。
譯文內容由第三人軟體翻譯。
