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AbbVie Announces Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C Infection
AbbVie Announces Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C
About this update from Abbvie Inc.
[{"type":"text","content":"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.\n\"The CHMP positive opinion for MAVIRET in acute hepatitis C represents an important step toward enabling earlier treatment, at a stage when the disease is often asymptomatic and may go undiagnosed,\" said Primal Kaur, M.D., senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie. \"This milestone aligns with global clinical guidance supporting treatment of suitable people with acute or chronic HCV infection. It also has the potential to help address unmet need, reduce the risk of onward transmission, and support global HCV elimination efforts.\"HCV is a serious blood-borne virus that can progress to chronic liver disease when left untreated.1 Acute HCV infection is frequently asymptomatic, and many individuals remain unaware of their infection until it has progressed to a later stage.1 Global clinical guidance supports treatment of nearly all people with HCV infection, reflecting the importance of early diagnosis and timely initiation of therapy.2 The newly released 2026 WHO Global Hepatitis Report further underscores this need, highlighting that diagnosis and treatment coverage remain far below global targets and rein...