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葛兰素史克Revolade新适应症获欧盟批准

2013-09-26 tomato 生物谷

葛兰素史克(GSK)宣布,Revolade(eltrombopag,艾曲波帕)新适应症申请获欧盟委员会(EC)批准,用于治疗慢性丙型肝炎(HCV)成人患者的血小板减少症(thrombocytopenia),从而使得这些患者能够启用基于干扰素的疗法,同时也可在干扰素治疗期间应用。 此前,Revolade于2010年获欧盟批准,用于慢性免疫(特发性)血小板减少症(ITP)的治疗。 血小板减


葛兰素史克(GSK)宣布,Revolade(eltrombopag,艾曲波帕)新适应症申请获欧盟委员会(EC)批准,用于治疗慢性丙型肝炎(HCV)成人患者的血小板减少症(thrombocytopenia),从而使得这些患者能够启用基于干扰素的疗法,同时也可在干扰素治疗期间应用。

此前,Revolade于2010年获欧盟批准,用于慢性免疫(特发性)血小板减少症(ITP)的治疗。

血小板减少症(血小板计数≤150Gi/L),可发生于慢性丙型肝炎患者,是肝功能损害的结果,同时也是聚乙二醇干扰素(pIFN)基础治疗的常见副作用。约25%的慢性HCV患者会出现血小板减少症,高达9%的患者会出现严重的血小板减少(血小板计数≤50Gi/L)。

血小板减少症会妨碍pIFN疗法的启用和维持治疗,从而降低患者实现持续病毒学应答(SVR)的机会,导致疾病发展更快,而SVR是丙型肝炎治疗的主要目标。

分析师之前预测,规模庞大的HCV市场,有望显着增加Revolade的潜在收益。由于全世界约有1.8亿人患有HCV慢性感染,预计该药的年销售额将达到20亿美元。

原文阅读

GSK's Revolade gets European approval for additional Hep C indication .GSK 24 September 2013, London UK.

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