Daklinza, when used in combination with
sofosbuvir, is an all-oral, once daily regimen that yields cure
rates of up to 100%
Daklinza + sofosbuvir offers potential cure
for a broad range of EU HCV patients, including those with advanced
liver disease, genotype 3 and protease inhibitor failures
Bristol-Myers Squibb Company (NYSE:BMY) today announced
that the European Commission has approved Daklinza (daclatasvir), a
potent, pan-genotypic NS5A replication complex inhibitor (in
vitro), for use in combination with other medicinal products across
genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C
virus (HCV) infection in adults. Daklinza, when used in combination
with sofosbuvir, is an all-oral, interferon-free regimen that
provided cure rates of up to 100% in clinical trials, including
patients with advanced liver disease, genotype 3 and those who have
previously failed treatment with protease inhibitors. Daklinza is
the first NS5A complex inhibitor approved in the European Union
(EU) and will be available for use in combination with other
medicinal products, providing a shorter treatment duration (12 or
24 weeks) compared to 48 weeks of treatment with interferon- and
ribavirin-based regimens.
Today’s approval allows for the marketing of Daklinza in all 28
Member States of the EU. The marketing authorization for Daklinza
follows an accelerated assessment by the Committee for Medicinal
Products for Human Use (CHMP), a designation that is granted to new
medicines of major public health interest.
“HCV is a challenging virus to overcome, requiring multiple
modes of attack. With the approval of Daklinza, we have a new class
of drug that disrupts the virus in two ways - by inhibiting both
viral replication and assembly - and when combined with other
compounds often results in cure among even the hardest-to-treat
patients,” said Michael P. Manns, MD, Professor and Chairman,
Department of Gastroenterology, Hepatology, and Endocrinology,
Hannover Medical School, Hannover, Germany.
Of the estimated nine million people living with HCV in the EU,
genotype 1 is the most common genotype, though distribution varies
across the region. The burden of liver disease and other
morbidities from HCV infection is significant in Europe, where HCV
accounts for 63% of liver transplants among patients with
virus-related liver disease. Patient populations with high unmet
needs include those with advanced liver disease, protease inhibitor
failure, genotype 3, HIV co-infected patients and those who have
undergone liver transplant.
“The eradication of HCV is in sight, and with today’s approval,
Daklinza, in combination with other agents, will be an important
option to achieve cure across many HCV genotypes and patient types
for those in the EU who are in dire need of new treatment choices,”
said Emmanuel Blin, Head of Worldwide Commercialization,
Bristol-Myers Squibb. “We are proud to have discovered, developed
and now brought to market this first-in-class NS5A replication
complex inhibitor. We look forward to our continued work with EU
health authorities to ensure Daklinza-based regimens are available
to patients as quickly as possible.”
The approval of Daklinza is supported by data from multiple
studies, including an open-label, randomized study of Daklinza with
sofosbuvir in genotypes 1, 2, and 3, including patients with no
response to prior therapy with telaprevir or boceprevir and
patients with fibrosis. Results showed that a regimen of Daklinza
with sofosbuvir achieved SVR12 (sustained virologic response 12
weeks after the end of treatment; a functional cure) in 99% of
treatment-naïve patients with HCV genotype 1, 100% of patients with
genotype 1 who had failed treatment with either telaprevir or
boceprevir, 96% of those with genotype 2 and 89% of those with
genotype 3.
In addition, the regimen resulted in low rates of
discontinuation (<1%) due to adverse events (AEs). The rate of
serious adverse events (SAEs) was low (4.7%). The most common
adverse events were fatigue, headache and nausea. Across clinical
studies, Daklinza-based regimens have been generally well tolerated
with low rates of discontinuation across a range of patients.
Ongoing and completed Daklinza studies have included more than
5,500 patients in a variety of all-oral regimens and with the
current interferon-based standard of care.
The safety of Daklinza for the treatment of hepatitis C has been
demonstrated in diverse patient populations that include elderly
patients, patients with advanced liver disease, post-liver
transplant recipients and patients co-infected with
HIV. No unique safety concerns have been identified in
patients who were treated with Daklinza across clinical studies and
in the early access program. Several of these studies are
ongoing.
Recommended regimens and treatment duration for Daklinza
combination therapy include:
HCV genotype and patient population
Treatment Duration Genotype 1 or 4
without cirrhosis
Daklinza + sofosbuvir
12 weeks
Consider prolongation of treatment to 24
weeks for patients with prior treatment including a NS3/4A protease
inhibitor (see sections 4.4 and 5.1).
Genotype 1 or 4 with compensated cirrhosis Daklinza +
sofosbuvir 24 weeks
Shortening treatment to 12 weeks may be
considered for previously untreated patients with cirrhosis and
positive prognostic factors such as IL28B CC genotype and/or low
baseline viral load.
Consider adding ribavirin for patients
with very advanced liver disease or with other negative prognostic
factors such as prior treatment experience.
Genotype 3 with compensated cirrhosis and/or treatment experienced
Daklinza + sofosbuvir + ribavirin 24
weeks Genotype 4 Daklinza + peginterferon alfa +
ribavirin 24 weeks of Daklinza in combination with
24-48 weeks of peginterferon alfa and ribavirin.
If the patient has HCV RNA undetectable at
both treatment weeks 4 and 12, all 3 components of the regimen
should be continued for a total duration of 24 weeks. If the
patient achieves HCV RNA undetectable, but not at both treatment
weeks 4 and 12, Daklinza should be discontinued at 24 weeks and
peginterferon alfa and ribavirin continued for a total duration of
48 weeks.
Daklinza monotherapy is not recommended. The Summary of Product
Characteristics will be available at www.ema.europa.eu. Commercial
availability of Daklinza in the EU will be determined by individual
Member States.
About Hepatitis C
Globally, there are 150 million people infected with HCV and of
that, an estimated 9 million people are living with hepatitis C in
the European Union (EU). Hepatitis C is a virus that infects the
liver and is transmitted through direct contact with infected blood
and blood products. Up to 90 percent of those infected with
hepatitis C will not spontaneously clear the virus and will become
chronically infected. According to the World Health Organization,
20 percent of people with chronic hepatitis C will develop
cirrhosis and, of those, about 5 to 7 percent of patients may
ultimately die of the consequences of infection.
About Bristol-Myers Squibb’s HCV Portfolio
Bristol-Myers Squibb’s research efforts are focused on advancing
late-stage compounds to deliver the most value to patients with
hepatitis C. At the core of our pipeline is daclatasvir, a potent
pan-genotypic NS5A complex inhibitor (in vitro), which continues to
be investigated in multiple treatment regimens and in people with
co-morbidities.
Daklinza was recently approved in Japan in combination with
Sunvepra (asunaprevir), a NS3/4A protease inhibitor. The
Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral,
interferon- and ribavirin-free treatment regimen for patients with
genotype 1 chronic HCV infection, including those with compensated
cirrhosis.
Applications for the daclatasvir Dual Regimen are also under
review by the U.S. Food and Drug Administration (FDA), which
granted priority review status and set a target review date under
the Prescription Drug User Fee Act (PDUFA) of November 30,
2014.
In 2014, the FDA granted Bristol-Myers Squibb’s investigational
daclatasvir Dual Regimen (daclatasvir + asunaprevir) Breakthrough
Therapy Designation for use as a combination therapy in the
treatment of genotype 1b HCV infection.
In 2013, Bristol-Myers Squibb’s investigational all-oral 3DAA
Regimen (daclatasvir/asunaprevir/BMS-791325) also received
Breakthrough Therapy Designation in the U.S., which helped to
expedite the start of the ongoing Phase 3 UNITY Program. Study
populations include non-cirrhotic naïve, cirrhotic naïve and
previously treated patients. The daclatasvir 3DAA Regimen is being
studied as a fixed-dose-combination treatment with twice daily
dosing.
Additional studies with daclatasvir in combination with
sofosbuvir are being conducted in high unmet need patients, such as
pre- and post-transplant patients, HIV/HCV co-infected patients and
patients with genotype 3 as part of the ongoing Phase 3 ALLY
Program.
About Bristol-Myers Squibb
Bristol-Myers Squibb is 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 http://www.bms.com or follow us
on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that Daklinza will be a commercially successful product.
Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect
Bristol-Myers Squibb's business, particularly those identified in
the cautionary factors discussion in Bristol-Myers Squibb's Annual
Report on Form 10-K for the year ended December 31, 2013, in our
Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K.
Bristol-Myers Squibb undertakes no obligation to publicly update
any forward-looking statement, whether as a result of new
information, future events or otherwise.
Bristol-Myers Squibb CompanyMedia:Carrie FernandezOffice:
+1 609-252-4831Cell: +1 215-859-2605carrie.fernandez@bms.comorJeff
SmithOffice: +33(0)1 58 83 83 21Cell: +33(0)6 03 99 40
18JR.Smith.paeurope@bms.comorInvestors:Ranya Dajani, +1
609-252-5330ranya.dajani@bms.comorRyan Asay, +1
609-252-5020ryan.asay@bms.com
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