MAY 6, 2019

FDA Grants Pediatric Indication for Mavyret for HCV

The FDA granted a pediatric indication to glecaprevir-pibrentasvir (Mavyret, AbbVie) tablets to treat all six genotypes of hepatitis C virus in children from 12 to 17 years. Glecaprevir-pibrentasvir was approved for adults in 2017.

According to the CDC, an estimated 2.7 to 3.9 million people in the United States have chronic HCV, and children born to HCV-positive mothers are at risk for HCV infection. It is estimated that there are 23,000 to 46,000 children in the United States with HCV