DAKLINZATM 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 DAKLINZATM
(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