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马立巴韦— Maribavir (Livtencity) —移植患者难治性CMV 感染

Updated: Nov 27, 2021

马立巴韦— Maribavir (Livtencity) —移植患者难治性CMV 感染|马立巴韦首个用于难治性移植后 CMV 感染的药物; 适用于 12 岁及以上的患者: 基因型耐药患者适用,无耐药基因患者同样适用。 FDA 周二晚批准了第一种用于治疗 12 岁及以上患者的难治性移植后巨细胞病毒 (CMV) 的药物。FDA 表示Maribavir (Livtencity) 是一种口服抗病毒药物,已被批准用于移植后 CMV 感染; 适用于12 岁及以上的儿童和成人,对现有抗病毒 CMV 治疗无效。适用于有或没有耐药突变的患者。 “当面临巨细胞病毒感染时,移植受者面临更大的并发症和死亡风险,”FDA 传染病办公室主任、医学博士 John Farley 在一份声明中说。 “今天的批准通过为该患者群体提供治疗选择,有助于满足显着未满足的医疗需求。”


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First Drug Approved for Refractory Post-Transplant CMV — Maribavir (Livtencity) okayed for patients ages 12 and up, with or without genotypic resistance The FDA approved the first drug for refractory post-transplant cytomegalovirus (CMV), in patients ages 12 and older, the agency announced late on Tuesday. Maribavir (Livtencity), an oral antiviral, was approved for children and adults who weigh at least 35 kg with post-transplant CMV that fails to respond to available antiviral CMV treatments, and is indicated for patients with or without resistance mutations, the agency said in a statement. "Transplant recipients are at a much greater risk for complications and death when faced with a cytomegalovirus infection," John Farley, MD, director of FDA's Office of Infectious Diseases, said in a statement. "Today's approval helps meet a significant unmet medical need by providing a treatment option for this patient population."



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