Schering-Plough wins Indian approval for hepatitis C combination therapy

Schering-Plough’s majority owned affiliate in India, Fulford India, has received approval for its Viraferonpeg, the pegylated interferon therapy in combination with Rebetol, for retreating adult patients with chronic hepatitis C whose prior treatment with interferon alpha and ribavirin combination therapy or interferon alpha monotherapy did not result in a sustained response.

The approval is based on results from the clinical study (EPIC3) in which 1,336 patients with moderate-to- severe fibrosis or cirrhosis who failed previous treatment with combination alpha interferon/ribavirin therapy were retreated with Viraferonpeg combination therapy.

In this study, virological response at week 12 of treatment was shown to be an important predictor for achieving a sustained virological response (SVR), with 57% of patients who had undetectable virus (HCV- RNA) at week 12 going on to achieve SVR with a 48-week course of therapy.

With this local approval in India, Viraferonpeg can now be used for re-treatment of a large and growing number of patients who failed previous hepatitis C (HCV) therapy and are in need of viable treatment options.

Viraferonpeg combination therapy is approved for re-treatment of HCV patients in Europe and US, and is the first pegylated interferon combination therapy to be approved for the re-treatment of chronic hepatitis C by the EU and FDA.

KG Ananthakrishnan, managing director of Fulford India, said: The approval of Viraferonpeg for the re-treatment of chronic Hepatitis offers hope to millions in India and highlights Schering-Plough’s steadfast commitment to ongoing research in the field of virology, with the aim of improving the health and quality of life for patients.