European Commission Grants AbbVie’s MAVIRET® (glecaprevir/pibrentasvir) Marketing Authorisation for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
By David Rowlands, Jul 31 2017 08:09AM
• MAVIRET is a new 8-week, pan-genotypic treatment for adult hepatitis C patients without cirrhosis and who are new to treatment
• Marketing authorisation is supported by 97 percent cure rate across this group of patients (patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C)
• MAVIRET is a pan-genotypic treatment indicated for use in patients across all stages of chronic kidney disease
• AbbVie’s investigational, pan-genotypic HCV treatment is also under Priority Review by the U.S. FDA
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the European Commission has granted marketing authorisation for MAVIRET®, a oncedaily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A inhibitor and pibrentasvir (40mg), an NS5A inhibitor (glecaprevir/pibrentasvir), for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). “Maviret represents a new 8-week pan-genotypic treatment option for adult patients without cirrhosis and who are new to treatment, who comprise the majority of the estimated 214,000 people living with HCV in the UK. The treatment combines two distinct antiviral agents and has high efficacy against most HCV genotypes, including those commonly associated with resistance to treatment,” said Dr Alice Butler, Medical Director, AbbVie UK.