ZURICH (Reuters) - Roche said on Monday the European Medicines Agency (EMA) has expanded the approval of its drug Pegasys plus ribavirin for the treatment of chronic hepatitis C virus (HCV) to children five years of age and older.
The new label for the medicine that was first approved in the European Union over 10 years ago includes children five years and older who have not received treatment and have tested positive for HCV, Roche said in a statement.
Pegasys, in combination with the antiviral ribavirin, is the foundation of treatment for chronic HCV in adults, Roche said.
Mother-to-child transmission of HCV is the most common route of acquiring the infection in children with approximately 65,000 children estimated to live with chronic HCV in Europe, Roche said.
Reporting by Silke Koltrowitz