Health Canada approves Daklinza for chronic hepatitis C

20 August 2015

Health Canada has granted Bristol-Myers Squibb’s (NYSE: BMY) Daklinza (daclatasvir) approval for the treatment of chronic hepatitis C (CHC) infection.

The approval includes a Notice of Compliance (NOC) for the treatment of adult patients with hepatitis C genotypes 1 and 2 with compensated liver disease including cirrhosis and a Notice of Compliance with conditions (NOC/c) for the treatment of genotype 3 patients with compensated liver disease including cirrhosis, offering Canadian physicians a new option to cure* these patients. When left untreated, HCV infection, can lead to serious liver disease and failure.

Daklinza (daclatasvir), an NS5A replication complex inhibitor, was approved by the US Food and Drug Administration last month (The Pharma Letter July 26), and was cleared for marketing in the European Union a year ago. In the USA, Bristol-Myers has set the price of Daklinza at $63,000 for a course of treatment.

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