Monday, March 18, 2013

Roche's Pegasys gets EU backing for chronic hepatitis C in children aged five years and older

The European Medicines Agency has expanded the approval of Swiss drug major Roche’s (ROG: SIX) Pegasys (peginterferon alfa-2a) plus ribavirin for the treatment of chronic hepatitis C virus (HCV) to include children and adolescents five years of age and older, who have not received treatment and who have tested positive for the virus.

Pegasys in combination with the antiviral ribavirin is the foundation of treatment for chronic HCV in adults. The drug was first approved in the European Union over 10 years ago.

“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,” said Hal Barron, Roche’s head of global product development and chief medical officer.

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. While the minority of children (4%-10%) born to infected mothers become infected, 80% of these children will develop chronic disease. Most children infected with chronic HCV do not have any symptoms, but the disease is progressive and can lead to advanced liver damage (cirrhosis), liver cancer and end-stage liver disease. The approval of Pegasys plus ribavirin provides an important additional treatment option for these children.

Clinical backing

The expanded EMA approval is based on a randomized controlled trial involving 114 children between the ages of five and 17 years with chronic HCV. The study assessed the efficacy of Pegasys in combination with ribavirin, as compared to treatment with Pegasys alone. The study showed that treatment with Pegasys plus ribavirin achieved sustained viral response (undetectable HCV ribonucleic acid [RNA] in the blood 24 weeks after completion of treatment) in over half of the children treated (53%), compared with 21% of children who received Pegasys alone. The majority of patients were infected with HCV genotype 1, a difficult-to-treat genotype. These results in children and adolescents are consistent with the pattern of response rates seen in adults infected with HCV genotype 1 treated with this combination of medicines


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