Baloxavir: First Global Approval

Baloxavir: First Global Approval
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DOI:
10.1007/s40265-018-0899-1
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发表时间:
2018-04-01
期刊:
影响因子:
11.5
通讯作者:
Heo, Young-A
Heo, Young-A
中科院分区:
医学1区
文献类型:
--
作者:
Heo, Young-A

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Baloxavir marboxil(Xofluza(TM); baloxavir)是Roche和Shionogi开发的口服帽依赖性核酸内切酶抑制剂。该药物通过抑制mRNA合成的起始来阻断流感病毒增殖。2018年2月,baloxavir在日本首次获得全球批准,用于治疗甲型或B型流感病毒感染。美国、欧盟和其他国家正在进行该适应症的III期开发。本文总结了baloxavir开发过程中的里程碑,导致全球首次批准用于甲型或B型流感病毒感染。
Baloxavir marboxil (Xofluza (TM); baloxavir) is an oral cap-dependent endonuclease inhibitor that has been developed by Roche and Shionogi. The drug blocks influenza virus proliferation by inhibiting the initiation of mRNA synthesis. In February 2018, baloxavir received its first global approval in Japan for the treatment of influenza A or B virus infections. Phase III development is underway in the USA, EU and other countries for this indication. This article summarized the milestones in the development of baloxavir leading to this first global approval for influenza A or B virus infections.