BMS files daclatasvir + asunaprevir in Japan for Hepatitis C
BMS announced on 1 November 2013, the submission of a New Drug Application (NDA) to Japan�s Pharmaceutical and Medical Devices Agency seeking the world�s first interferon-free and ribavirin-free treatment regimen for patients with Chronic Hepatitis C. The submission to Japan is based on results from a Phase III study demonstrating that the 24-week, all-oral, interferon-free and ribavirin-free regimen of daclatasvir (DCV) and asunaprevir (ASV) achieved an overall sustained virologic response 24 weeks after the end of treatment (SVR24) of 84.7% in Japanese patients with Chronic Hepatitis C (HCV) Genotype 1b who were either interferon-ineligible/intolerant (87.4% SVR24) or non-responders (null and partial) to interferon-based therapies (80.5% SVR24).
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