FDA extends indications for Harvoni and Sovaldi to pediatric patients

The US Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17.

Harvoni and Sovaldi, both from US biotech major Gilead Sciences (Nasdaq: GILD), were previously approved to treat HCV in adults. Gilead’s HCV product sales, which consist of Harvoni, Sovaldi and Epclusa (sofosbuvir/velpatasvir), were $14.8 billion for full-year 2016, compared with $19.1 billion for 2015.

These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. 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, the FDA noted.