BMS Receives FDA Complete Response Letter

Bristol-Myers Squibb reports that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the company’s new drug application (NDA) for daclatasvir, an NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C (HCV).

The initial daclatasvir NDA submitted to the FDA focused on its use in combination with asunaprevir, an NS3/4A protease inhibitor. Given the withdrawal of asunaprevir by Bristol-Myers Squibb in Octobe 2014, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV. Bristol-Myers Squibb is in discussions with the FDA about the scope of these data.

Source: Bristol-Myers Squibb

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