AbbVie Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for their oral pangenotypic direct acting antiviral (DAA) therapy, MAVYRET® (glecaprevir/pibrentasvir). This expansion allows the treatment of adults and pediatric patients aged three years and older with acute or chronic hepatitis C virus (HCV) infection, without cirrhosis or with compensated cirrhosis. MAVYRET is now the first and only DAA therapy approved to treat patients with acute HCV in just eight weeks, boasting a 96% cure rate. This approval supports global clinical guidelines to advance testing and treatment for HCV, contributing to public health goals for disease elimination. The FDA also granted Breakthrough Therapy Designation for MAVYRET, expediting its development and review due to its potential substantial improvement over existing therapies.
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