[Press release] AbbVie announces positive CHMP opinion for MAVIRET® (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C infection

AbbVie press release

NORTH CHICAGO, Ill., May 22, 2026 — 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 therapy for the treatment of acute hepatitis C infection 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.

Acute HCV infection is frequently asymptomatic, and many individuals remain unaware of their infection until it has progressed to a later stage. Global clinical guidance supports treatment of nearly all people with HCV infection, reflecting the importance of early diagnosis and timely initiation of therapy.

The positive opinion is supported by data from the Phase 3, multicenter, single-arm prospective M20-350 study evaluating the safety and efficacy of MAVIRET eight-week treatment in adults with acute HCV infection. In the study, MAVIRET demonstrated a 96% cure rate, as measured by sustained virologic response at 12 weeks after treatment (SVR₁₂), with a safety profile generally consistent with prior experience; the most common adverse events were fatigue, diarrhea, headache and asthenia.

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