FDA approves first treatment for all genotypes of hepatitis C in pediatric patients

The US Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17.

Mavyret, developed by US biopharma firm AbbVie (NYSE: ABBV), was previously approved to treat HCV in adults in 2017. The drug is already a big earner for AbbVie, generating sales of $790 million in the first quarter of this year and $3.44 billion in full-year 2018.

“Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV infection,” said Dr Jeffrey Murray, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval represents another treatment option for children and adolescents with HCV infection, but for the first time, in all genotypes of HCV.”