US biopharmaceutical company AbbVie (NYSE:ABBV) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has 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.

A final decision by the European Commission 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.

The CHMP's positive opinion for MAVIRET in acute hepatitis C was based on the data from the Phase 3 multicentre, 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, the product 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.

MAVIRET is approved in Canada, Australia, the United States (as MAVYRET), Saudi Arabia, New Zealand, Taiwan, and Argentina, for the treatment of acute and chronic HCV infection in adults and children aged three years and older.