Medivir Says Simeprevir Approved In USA To Treat Hepatitis C

(RTTNews) - Medivir AB (MVRBF.PK) announced that U.S. Food and Drug Administration or FDA has approved simeprevir for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy with ribavirin.

"The USA approval is a large and important milestone in the global strategy that our partner Janssen has for simeprevir, to offer a new treatment option to many different hepatitis C patient groups," said Maris Hartmanis CEO, Medivir.

The simeprevir approval in the USA is based on several studies of patients with CHC genotype 1 infection. These trials include treatment-naïve patients (QUEST-1 and QUEST-2), and patients who have failed prior treatment with pegylated interferon and ribavirin; in PROMISE and ASPIRE. The USA approval triggers a milestone payment of 10 million euros to Medivir.