AbbVie has announced that the European Commission has approved MAVIRET® (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus infection in adults and children aged three years and older. The approval also expands the medicine’s use across the European Union for both acute and chronic hepatitis C, strengthening AbbVie’s antiviral portfolio.
The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is supported by Phase 3 data from the M20-350 study. According to the company, MAVIRET delivered a 96% cure rate, measured as sustained virologic response 12 weeks after treatment, with a safety profile consistent with prior experience.
AbbVie Chief Executive Officer Robert Michael said, “This approval represents an important advancement for patients with acute hepatitis C, providing a well-established treatment option that can help support broader efforts toward elimination of the virus.”
The company said the eight-week, oral pangenotypic regimen offers a convenient treatment option for patients with acute HCV infection. AbbVie added that the approval marks another step in expanding access to hepatitis C treatment across Europe.
