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- AbbVie (NYSE:ABBV) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved a label expansion for its oral antiviral therapy Mavyret, developed with partner Enanta Pharmaceuticals (NASDAQ:ENTA), against the Hepatitis C virus.
- Accordingly, the treatment combining antiviral agents glecaprevir/pibrentasvir,= will be available in the U.S. for adults and children aged three years and older with acute or chronic HCV infection. To qualify for the eight-week treatment, patients should be free of cirrhosis or compensated cirrhosis.
- The decision was backed by data from a Phase 3, single-arm prospective study in which Mavyret was found to be safe and effective for those with acute HCV.
- The treatment was first approved by the FDA in 2017 for newly diagnosed adult patients with HCV.