Health Canada approves DAKLINZA(TM) (daclatasvir) for the treatment of chronic Hepatitis C infection across multiple genotypes including genotype 3

DAKLINZA^TM in combination with sofosbuvir is the first 12-week, all-oral therapy that offers SVR12 for the vast majority of non-cirrhotic genotype 3 patients

MONTREAL, Aug. 20, 2015 /CNW/ - Health Canada has granted the Bristol-Myers Squibb Canada medication DAKLINZA^TM (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." 

DAKLINZA is a potent, pan-genotypic NS5A replication complex inhibitor (in vitro) that has been approved for use in combination with sofosbuvir (marketed in Canada by Gilead Sciences Canada Inc. as SOVALDI) as a convenient, all-oral, once-daily regimen.  DAKLINZA is indicated as a 12-week regimen in combination with sofosbuvir for the treatment of genotype 1 and genotype 3 patients without cirrhosis making this the first ribavirin-free 12 week treatment regimen for genotype 3 patients. DAKLINZA is indicated as a 24 week regimen in genotype 2 patients and for genotype 1 and 3 patients with cirrhosis.

The Health Canada approval of DAKLINZA is supported by data from an open-label, randomized study of DAKLINZA with sofosbuvir with or without ribavirin in genotypes 1, 2, and 3, including genotype 1 patients with no response to prior protease inhibitors (telaprevir or boceprevir). Results showed that a regimen of DAKLINZA with sofosbuvir achieved SVR12** (sustained virologic response 12 weeks after the end of treatment) in 99% of treatment-naïve patients with HCV genotype 1, 100% of patients who had not achieved SVR with either telaprevir or boceprevir, 94% of treatment-naive patients with genotype 2 and 100% of treatment-naive with genotype 3 who had received the indicated dose of DAKLINZA in combination with sofosbuvir.**

In Canada, genotypes 1, 2 and 3 account for 64%, 14% and 20% of hepatitis C infections respectively.

"Bristol-Myers Squibb Canada is very pleased to contribute to the revolution of treatment outcomes for hepatitis C patients with the approval in Canada of DAKLINZA. This approval will provide an exciting new option to address an unmet need for patients with hepatitis C to benefit from therapy," said Nawal Peacock, President and General Manager, Bristol-Myers Squibb Canada.

DAKLINZA has high cure* rates and benefits hepatitis C patients most in need of additional options – patients with genotype 3, with advanced fibrosis or cirrhosis or those who have failed previous protease inhibitor therapy. Canadian patients who are prescribed DAKLINZA will be supported by the comprehensive CLAIRE Patient Support Program.

Canadian experts comment on the approval of DAKLINZA (daclatasvir)
"Great strides have been made in the past few years in effectively curing hepatitis C in many patients thanks to new treatments.  However, there are important populations that have remained very challenging to treat - particularly those with genotype 3. The approval of daclatasvir provides us a new option for these patients. It's an important new addition in the fight against hepatitis C."
– Dr. Alnoor Ramji, Clinical Associate Professor of Medicine, Division of Gastroenterology, University Of British Columbia, Vancouver

"Patients with genotype 3 hepatitis C infection, which make up about one in five cases of hepatitis C infection in Canada, have proven difficult to treat with existing therapies. Having the new daclatasvir and sofosbuvir combination, which has shown very positive results in studies in this population, is a very encouraging development in moving towards the ultimate elimination of the infection in most patients."
– Dr. Paul Marotta, Medical Director of Liver Transplantation, London Health Sciences Centre and Associate Professor, University of Western Ontario, London

DAKLINZA safety information
The safety of DAKLINZA for the treatment of hepatitis C has been demonstrated in diverse patient populations, including genotypes 1-3, patients with advanced fibrosis or cirrhosis and patients who are interferon-intolerant or who have not previously responded to first-generation protease inhibitor therapy.

DAKLINZA in combination with sofosbuvir resulted in low rates of discontinuation (1%) due to adverse events (AEs). The rate of serious adverse events (SAEs) was low (7%). The most common adverse events were fatigue, headache and nausea.

Ongoing and completed DAKLINZA studies have included more than 13,000 patients in a variety of all-oral regimens. Across the clinical studies, DAKLINZA-based regimens have been generally well tolerated with low rates of discontinuation across a range of patients. 

About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Up to 90% of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, left untreated up to 20% of people with chronic hepatitis C will develop cirrhosis; of those, up to 25% may progress to liver cancer. An estimated 350,000 to 400,000 people in Canada are chronically infected with HCV, but about 21% of those people are unaware and are undiagnosed.

About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bmscanada.ca.

*A functional cure is defined as a sustained virologic response 12 weeks after the end of treatment (SVR₁₂).

**SVR rates excluding patients that received a 7 day lead-in with sofosbuvir monotherapy.

DAKLINZA™ is a trademark of Bristol-Myers Squibb Holdings Ireland, used under licence by Bristol-Myers Squibb Canada.

SOVALDI^® is a registered trademark of Gilead Sciences Ireland UC or its related companies.

SOURCE Bristol-Myers Squibb Canada