Market Overview

Daclatasvir Marketing Authorization Application for Treatment of Chronic Hepatitis C Validated for Accelerated Regulatory Review by EMA

Bristol-Myers
Squibb (NYSE: BMY) today announced that the European
Medicines Agency (EMA) has validated the company's marketing
authorization application (MAA) for the use of daclatasvir (DCV), an
investigational NS5A complex inhibitor, for the treatment of adults with
chronic hepatitis C (HCV) with compensated liver disease, including
genotypes 1, 2, 3, and 4. The application seeks the approval of
daclatasvir for use in combination with other agents, including
sofosbuvir, for the treatment of chronic hepatitis C. The MAA validation
marks the start of an accelerated regulatory review process for DCV,
which has the potential, when used in combination with other agents, to
address a high unmet need in the European Union (EU), where an estimated
9

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Posted-In: News Guidance Contracts FDA Management Global

 

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