FDA approves new indication for AbbVie’s Mavyret
AbbVie has received the Food and Drug Administration’s nod for a new indication for Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus, or HCV genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).
Mavyret is now the first eight-week treatment approved for all treatment-naïve adult and certain pediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.
“This approval provides a treatment duration of eight weeks for both pediatric and adult patients with compensated cirrhois regardless of HCV genotype; meaning that an eight-week treatment regimen is available for any treatment-naïve HCV patient, regardless of cirrhosis status or genotype,” said Jeffrey Murray, deputy director of the division of antiviral products in the FDA’s Center for Drug Evaluation and Research. “Mavyret is a combination of direct-acting antiviral drugs that reduce the amount of HCV in the body to undetectable levels by preventing the virus from multiplying, and in most cases, curing HCV infection.”