29 Mar 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Janssen Research & Development submitted a New Drug Application (NDA) to the US FDA seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients.
The regulatory submission for simeprevir is supported in part by data from three pivotal phase III studies, including QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment.
n each study, participants were treated with one 150 mg simeprevir capsule once daily for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks. Primary efficacy data from the phase III studies will be presented at an upcoming medical meeting.
Mr Wim Parys, global head of development, infectious diseases and vaccines, Janssen, said that, "Hepatitis C is a complicated disease and genotype 1 hepatitis C can be particularly difficult to cure. Given the complexity and diversity of the patient population, physicians need multiple options to provide their patients a chance at treatment success. The US filing represents an important step forward in bringing simeprevir to market and in helping to battle this challenging disease."