Baloxavir: First Global Approval

• Published in: Drugs (New York, N.Y.) Vol. 78; no. 6; pp. 693 - 697
• Main Author: Heo, Young-A
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.04.2018; Springer Nature B.V
• Subjects: AdisInsight Report; Adolescent; Adult; Adults; Agreements; Antiviral Agents - administration & dosage; Antiviral Agents - chemistry; Antiviral Agents - pharmacokinetics; Antiviral Agents - therapeutic use; Avian flu; Child; Clinical trials; Collaboration; Drug Approval; Drug dosages; Endonuclease; Health care; Humans; Infections; Infectious diseases; Influenza; Influenza A; Influenza A virus; Influenza B virus; Influenza, Human - drug therapy; Internal Medicine; Japan; Laboratories; Medicine; Medicine & Public Health; Middle Aged; Mortality; Oxazines - administration & dosage; Oxazines - chemistry; Oxazines - pharmacokinetics; Oxazines - therapeutic use; Pandemics; Pharmacology/Toxicology; Pharmacotherapy; Pyridines - administration & dosage; Pyridines - chemistry; Pyridines - pharmacokinetics; Pyridines - therapeutic use; RNA, Messenger - antagonists & inhibitors; Thiepins - administration & dosage; Thiepins - chemistry; Thiepins - pharmacokinetics; Thiepins - therapeutic use; Transcription; Triazines - administration & dosage; Triazines - chemistry; Triazines - pharmacokinetics; Triazines - therapeutic use; Viruses; Young Adult; Japan; United States > US
• ISSN: 0012-6667; 1179-1950
• DOI: 10.1007/s40265-018-0899-1

Baloxavir marboxil (Xofluza™; 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.