EMA CHMP adopts positive opinion for Bristol-Myers Squibb’s Daklinza for HCV treatment

Bristol-Myers SquibbJun 27 2014

Bristol-Myers Squibb Company (NYSE:BMY) today announced 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. This is the first positive opinion given by the CHMP for an NS5A complex inhibitor and will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).

"Through Bristol-Myers Squibb's Early Access Programs in Europe more than 2,000 HCV patients with advanced liver disease have already been treated with Daklinza, in combination with sofosbuvir," said Elliott Levy, Head of Specialty Development, Bristol-Myers Squibb. "We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe."

Recently included in the European Association for the Study of the Liver's (EASL) clinical practice guidelines for the management of HCV infection across genotypes, the EU marketing authorization application for Daklinza has gone through an accelerated review process. The positive CHMP opinion was based on data from multiple studies of Daklinza with other HCV agents, including sofosbuvir, for the treatment of chronic hepatitis C.

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

Ongoing and completed Daklinza studies have included more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care. Across clinical studies, Daklinza-based regimens have been generally well tolerated with low rates of discontinuations across a range of patients.