AbbVie announces FDA approval for MAVYRET expanded indication

AbbVie (ABBV) announced that the U.S. Food and Drug Administration approved a label expansion for MAVYRET, an oral pangenotypic direct acting antiviral therapy. It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus infection without cirrhosis or with compensated cirrhosis. With this approval, MAVYRET is the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate.The label expansion was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVYRET eight-week treatment in adults with acute HCV infection. The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV. The majority of the adverse events reported were mild or moderate in severity. The most common adverse events were fatigue, asthenia, headache, and diarrhea.