CHMP Backs Bristol-Myers Squibb's Daclatasvir For Hep C In EU

Bristol-Myers Squibb reported that it has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its Daklinza (daclatasvir) in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adult patients in the EU.

Daclatasvir is an investigational pan-genotypic NS5A complex inhibitor currently under development in the Phase III ALLY program as part of a combination with sofosbuvir in HIV/HCV co-infected patients, patients with genotype 3, and other patient groups with unmet medical needs. The EU marketing authorization application for Daklinza went through an accelerated review process. In addition, the drug has been granted priority review status by the FDA in the U.S. Bristol-Myers Squibb has also filed regulatory applications for Daklinza-based regimens in Japan.

Elliott Levy, Head of Specialty Development at Bristol-Myers Squibb, said, “We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe.” Levy said that the drug has been available in the EU through the company’s Early Access Programs in Europe as a combination treatment with sofosbuvir for HCV patients with advanced liver disease.

HCV affects 150 million patients around the world, with approximately 9 million living in the EU. Up to 90 percent of infected individuals will not spontaneously clear the virus and will stay chronically infected. Twenty percent of people with HCV will later develop cirrhosis, with 5 to 7 percent ultimately dying from the infection, according to the World Health Organization.

The company is conducting ongoing studies in addition to completed ones for the drug which involve over 5,500 patients in a range of all-oral regimens and standard interferon-based standard of care. BMS reports that Daklinza-based regimens have been generally tolerated and discontinuation rates have been low across a range of patient groups.

The CHMP recommendation is the first for an NS5A complex inhibitor and is set to be reviewed by the European Commission.