Janssen-Cilag applies for EU approval of hepatitis C drug

Janssen-Cilag is to seek approval from the European Medicines Agency (EMA) for a new investigational treatment for the chronic genotype 1 hepatitis C virus (HCV).

A marketing authorisation application has been submitted for telaprevir, a selective protease inhibitor designed to be used alongside pegylated-interferon and ribavirin, the current standard of care.

The application is based on positive data from phase III clinical trials, which demonstrated the treatment's efficacy in achieving sustained virologic response among patients.

Telaprevir has been accepted by the EMA for accelerated assessment, a status granted to treatments that are thought to be of major public health interest.

Johan Van Hoof, global therapeutic area head for infectious diseases and vaccines at Janssen, said: "The EMA submission for telaprevir is a landmark in the treatment of HCV and demonstrates our dedication to addressing unmet medical needs."

In October 2010, the company began construction of a new European distribution centre, which will be located in La Louviere in Belgium.