EMA recommends INCIVO for hepatitis C virus
Tibotec Virco-Virology BVBA, part of Janssen Pharmaceutical, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of INCIVO (telaprevir), a direct acting antiviral (DAA) for the treatment of chronic genotype-1 hepatitis C virus (HCV), in combination with pegylated-interferon and ribavirin, the previously accepted standard of care.
The CHMP positive opinion is based on results from three phase III clinical trials, ADVANCE, REALIZE and ILLUMINATE, which evaluated the efficacy and safety of telaprevir in combination with pegylated-interferon and ribavirin in more than 2,290 treatment-naïve and previously-treated genotype 1 HCV patients.
The CHMP positive opinion is a critical step in the approval process and will be considered by the European Commission, which has authority to approve medicines for use throughout the European Union. Telaprevir was approved by the FDA in May 2011 and is marketed by Vertex Pharmaceuticals under the brand name INCIVEK[TM].