BMS filed combination daclatasvir + asunaprevir for Genotype 1b Hepatitis C
Bristol-Myers Squibb Company has announced that they have submitted new drug applications (NDAs) with the FDA for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor. The data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b Hepatitis C (HCV). The DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes.
In January 2014, the European Medicines Agency (EMA) validated the company�s marketing authorization application for the use of DCV in combination with other agents for the treatment of adults with HCV with compensated liver disease, including genotypes 1, 2, 3, and 4, and this application is under accelerated review.
In addition, NDAs for DCV and ASV are under priority review by Japan�s Pharmaceutical and Medical Devices Agency for patients with chronic HCV genotype 1b, classified as either interferon-ineligible na�ve/intolerant or non-responders to interferon and ribavirin.
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