CHMP recommends extension to indication for Pegasys (peg interferon alfa 2a) in hepatitis B.- Roche.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Pegasys (peg interferon alfa 2a), from Roche, in hepatitis B. The CHMP adopted an extension to an existing indication as follows: “Pegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels. With respect to the decision to initiate treatment in paediatric patients."

The full indication will be: Adult patients: Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (ALT) and histologically verified liver inflammation and/or fibrosis. Paediatric patients 3 years of age and older: Pegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels.