AbbVie Announces Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C Infection
PR Newswire
NORTH CHICAGO, Ill., May 22, 2026
The positive opinion is supported by data from the Phase 3 M20-350 study evaluating the safety and efficacy of MAVIRET® in adults with acute hepatitis C virus (HCV) infection.MAVIRET is a direct-acting antiviral (DAA) treatment currently approved in the European Union for chronic HCV infection in adults and children aged 3 years and older.Acute HCV infection is often asymptomatic, highlighting the importance of early diagnosis and treatment to help reduce transmission, long-term liver-related complications, and support HCV elimination efforts.NORTH CHICAGO, Ill., May 22, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of MAVIRET® (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy for the treatment of acute hepatitis C infection (HCV) in adults and children aged 3 years and older. The final European Commission decision is expected in the third quarter of 2026. If approved, MAVIRET would be indicated for both acute and chronic hepatitis C (HCV) infection in the European Union.
