FDA approve expansion of the paediatric indication of sofosbuvir/velparasvir (Epclusa) for the treatment of chronic hepatitis C virus to include children from the age of 3 years old and above

Approval is based on data from a Phase 2 trial (n=41) which found Epclusa achieved a sustained virologic response (SVR12) or cure rate of 83% among all patients at 12 weeks after treatment completion. Recommended dosage in children ages 3 years and older is based on weight.

Source:

Biospace Inc.