Roche receives EU approval for juvenile hepatitis C treatment

Roche has received regulatory approval from the European Union for a product that has been designed to treat chronic hepatitis C in children.

The company has announced that the European Medicines Agency (EMA) has expanded its level of approval for Pegasys – peginterferon alfa-2a – to be used with the antiviral ribavirin for the treatment of this condition in patients over the age of five.

This method of treatment was first granted approval more than ten years ago, but had only previously been eligible for use when treating older sufferers of the disease.

Hal Barron, chief medical officer and head of global product development at Roche, said Hepatitis C can ultimately lead to the development of advanced liver disease if left untreated.

"This approval provides doctors and parents of children as young as five with a treatment combination for this infection, he added.

The EMA made this decision after conducting a randomised trial of 114 children between the ages of five and 17.