Bristol-Myers Squibb (BMS) reports that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Daklinza (daclatasvir), an investigational, potent pan-genotypic NS5A complex inhibitor (in vitro), be granted approval for use in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults. According to BMS, this is the first positive opinion given by the CHMP for an NS5A complex inhibitor. The application  will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. 

Applications for Daklinza-based regimens are also pending in Japan and the US. A decision from Japan's Pharmaceutical and Medical Devices Agency is expected soon, and the US Food and Drug Administration (FDA) has granted priority review status and set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 30, 2014.

In 2014, FDA granted BMS’s investigational Daclatasvir Dual Regimen (daclatasvir + asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection.

In 2013, BMS’s investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation in the US. The daclatasvir 3DAA regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

Daclatasvir also is being studied in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III program.

Source: Bristol-Myers Squibb