J&J reports Japanese simeprevir data
The Janssen R&D Ireland unit of Johnson & Johnson (NYSE:JNJ) presented data on Thursday at the Japan Society of Hepatology meeting in Tokyo from the four Japanese Phase III CONCERTO trials evaluating simeprevir ( TMC435) to treat chronic HCV genotype 1 infection. Data from the trials are supporting the NDA that the pharma submitted to Japan's Ministry of Health, Labor and Welfare (MHLW) in February for simeprevir to treat HCV genotype 1 infection.
In the double-blind CONCERTO-1 trial, once-daily oral simeprevir for 12 weeks plus peginterferon alfa-2a and ribavirin for 24 or 48 weeks met the primary endpoint in 183 treatment-naïve patients of a greater proportion of patients achieving a sustained virologic response (SVR) 12 weeks after the end of treatment vs. placebo plus peginterferon and ribavirin (88.6% vs. 61.7%, p<0.0001). CONCERTO-2, CONCERTO-3 and CONCERTO-4 were open-label trials evaluating once-daily simeprevir in combination with peginterferon alfa-2a and ribavirin in treatment-naïve patients and in patients who failed to respond to or who relapsed after previous interferon-based therapy. ...