Japan next to give AbbVie's hep C regimen priority review

14 March 2017

US drugmaker AbbVie (NYSE: ABBV) has announced that priority review has been granted by the Japanese Ministry of Health, Labor and Welfare (MHLW) for its investigational, pan-genotypic, ribavirin-free regimen of glecaprevir/pibrentasvir (G/P) for the treatment of all major genotypes of the chronic hepatitis C virus (HCV).

This priority review follows European Medicines Agency (EMA) accelerated assessment and US Food and Drug Administration (FDA) priority review designations in December 2016 and January 2017 respectively.

AbbVie only submitted its new drug application for G/P in Japan last month.

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