Horizon scanning: Regulatory application filed in Japan for simeprevir for the treatment of genotype 1 hepatitis C

Source: BioSpace Area: News According to a BioSpace report, a regulatory application has been submitted to the Japanese Ministry of Health & Welfare authorities seeking approval for simeprevir, administered with pegylated interferon (Peg-IFN) and ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C patients who are treatment naïve, prior non responders or relapsed following treatment with Peg-IFN with or without RBV.   Simeprevir is an oral once-daily NS3/4A protease inhibitor in late Phase III clinical development. The application is supported by data from four Japanese phase III clinical studies including patients with genotype 1 HCV. Further ongoing Phase III studies are evaluating simeprevir in treatment-naïve and treatment-experienced HIV-HCV co-infected patients and in HCV genotype 4 patients.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news