Health Canada approves Daklinza (daclatasvir) for the treatment of chronic hepatitis C infection across multiple genotypes including genotype 3

20 August 2015 - Health Canada has granted the Bristol-Myers Squibb Canada medication 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.

The NOC/C for Daklinza was issued on the basis of promising evidence of clinical effectiveness of Daklinza in genotype 3 patients pending the submission of final clinical study results of the ALLY-3 study. This indication marks the first interferon and ribavirin-free all oral regimen for the treatment of genotype 3 patients to be approved in Canada.

“The approval of Daklinza in Canada is good news on many levels. On a personal note, I’m able to get on with my life today infection-free because of this treatment. To be told that you are actually cured is pretty remarkable,” said Joan King, Vice President of a hepatitis C patient group in Canada. “This is another important milestone for hepatitis C patients across genotypes. But the significance of this approval is the impact it will have on the one in five patients who have genotype 3 and are being treated but not achieving cure rates like we’re seeing with those living with other genotypes. This gives them a chance to hear the very same words that many of us are being told – you are cured.”

For more details, go to: http://www.bmscanada.ca/en/news/release/health-canada-approves-daklinza-daclatasvir-for-the-treatment-of-chronic-hepatitis-c-infection-acros

Michael Wonder

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Michael Wonder