
AbbVie receives European Commission approval for MAVIRET in acute hepatitis C
- The European Commission approved AbbVie's MAVIRET to treat acute hepatitis C virus in adults and children aged three and older.
- Following the regulatory announcement, the company's stock price closed up at $230.01.
- The regulatory clearance advances the long-term corporate strategy of expanding global pediatric and antiviral product portfolios.
AbbVie (NYSE:ABBV) said the European Commission has granted approval for its oral antiviral MAVIRET (glecaprevir/pibrentasvir) to treat acute hepatitis C virus (HCV) infection in adults and pediatric patients aged 3 years and older with compensated liver disease, with or without cirrhosis.
With this approval, MAVIRET becomes the only treatment in the European Union approved for both acute and chronic HCV infection.
The approval was supported by data from a Phase 3 study evaluating an eight-week regimen, which demonstrated high efficacy rates along with a safety profile consisting mainly of mild to moderate adverse events, including fatigue, diarrhea, headache, and asthenia.
The company stated that this development aligns with its strategy to scale antiviral treatments across multiple age brackets.