正文摘录:
TheU.S.FoodandDrugAdministrationhasapprovedEnspryng(satralizumab-mwge)forthetreatmentofneuromyelitisopticaspectrumdisorder(NMOSD)inadultswithaparticularantibody–patientswhoareanti-aquaporin-4orAQP4antibody-positive.NMOSDisarareautoimmunediseaseofthecentralnervoussystemthatmainlyaffectstheopticnervesandspinalcord.Enspryngisthethirdapprovedtreatmentforthedisorder.
美国食品和药物管理局已经批准Enspryng(satralizumab-mwge)用于治疗具有特定抗体的成人视神经髓炎(NMOSD)——抗水通道蛋白4或AQP4抗体阳性的患者。NMOSD是一种罕见的中枢神经系统自身免疫性疾病,主要累及视神经和脊髓。Enspryng是第三种被批准的治疗方法。
“Untillastyear,therewerenoFDA-approvedtreatmentsforpatientswiththisrare,debilitatingandsometimesfataldisease.Nowtherearethree,”saidBillyDunn,M.D.,directoroftheOfficeofNeuroscienceintheFDA’sCenterforDrugEvaluationandResearch.“Today’sapprovalofEnsprynghighlightstheFDA’s