Trials & Filings

EMA Accepts HCV MAA from BMS

Begins accelerated review process

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Bristol-Myers Squibb‘s 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, has been validated by the EMA. 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 proc...

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