Janssen submits Marketing Authorization Application to EMA for simeprevir approval
Published on April 25, 2013 at 3:09 AM
Medivir AB (OMX: MVIR) (STO:MVIR-B) today announces that Janssen-Cilag International NV (Janssen) today has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) seeking approval for simeprevir (TMC435).
"The filing of simeprevir in Europe represents the third filing in major regions in the last two months. It shows the commitment and speed with which our partner Janssen acts in the process of bringing new hepatitis C treatments to the market", said Maris Hartmanis, CEO of Medivir AB.
The regulatory submission for simeprevir is supported by data from three phase III studies in patients with genotype 1 hepatitis C: QUEST-1 and QUEST-2 in treatment-naïve patients, and PROMISE in patients who have relapsed after prior interferon-based treatment. The filing for the treatment of patients with the genotype 4 virus is based on phase II data and an ongoing phase III study.
Simeprevir is a new generation NS3/4A protease inhibitor, administered as a capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 and 4 chronic hepatitis C in adult patients. Genotype 1 is the most prevalent form of hepatitis C virus (HCV) worldwide.