Janssen files for European approval of hepatitis drug

Janssen has applied for European regulatory approval of simeprevir, a new treatment for adult patients with chronic hepatitis C genotype 1 and 4.

A marketing authorisation application has been filed with the European Medicines Agency for approval of the once-daily oral therapy, which is intended for use with pegylated interferon and ribavirin among patients with compensated liver disease who are treatment-naive or have failed previous interferon therapy.

This filing is supported by data from a trio of phase III clinical trials – Quest-1, Quest-2 and Promise – which have supported the safety and efficacy of the new drug.

Results from Quest-1 and Quest-2 were highlighted by the company earlier this week showing that simeprevir was able to deliver sustained virologic response among the majority of patients.

Wim Parys, global head of development for infectious diseases and vaccines at Janssen, said: "This filing of simeprevir in Europe represents an important step forward in the process of bringing simeprevir to market and helping to battle this challenging disease."