Bristol-Myers Squibb Receives Positive CHMP Opinion for Daklinza® (daclatasvir) for Treatment of Chronic Hepatitis C in the ...
June 27 2014 - 7:00AM
Business Wire
Daklinza in combination with other agents
would offer a potential cure for HCV patients with high unmet needs
who urgently require treatment, if approved
Bristol-Myers Squibb Company (NYSE:BMY) today announced
that the Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMA) has adopted a positive opinion
recommending that Daklinza® (daclatasvir), an investigational,
potent pan-genotypic NS5A complex inhibitor (in vitro), be granted
approval for use in combination with other medicinal products for
the treatment of chronic hepatitis C virus (HCV) infection in
adults. This is the first positive opinion given by the CHMP for an
NS5A complex inhibitor and will now be reviewed by the European
Commission, which has the authority to approve medicines for the
European Union (EU).
“Through Bristol-Myers Squibb’s Early Access Programs in Europe
more than 2,000 HCV patients with advanced liver disease have
already been treated with Daklinza, in combination with
sofosbuvir,” said Elliott Levy, Head of Specialty Development,
Bristol-Myers Squibb. “We anticipate that, if approved,
Daklinza-based regimens will play a significant role in treating
HCV patients with high unmet medical needs across Europe.”
Recently included in the European Association for the Study of
the Liver’s (EASL) clinical practice guidelines for the management
of HCV infection across genotypes, the EU marketing authorization
application for Daklinza has gone through an accelerated review
process. The positive CHMP opinion was based on data from multiple
studies of Daklinza with other HCV agents, including sofosbuvir,
for the treatment of chronic hepatitis C.
Applications for Daklinza-based regimens are also pending in
Japan and the U.S. A decision from Japan’s Pharmaceutical and
Medical Devices Agency is expected soon, and the U.S. Food and Drug
Administration has granted priority review status and set a target
review date under the Prescription Drug User Fee Act (PDUFA)
of November 30, 2014.
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. Across clinical studies,
Daklinza-based regimens have been generally well tolerated with low
rates of discontinuations across a range of patients.
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, an
investigational, potent pan-genotypic NS5A complex inhibitor (in
vitro), which continues to be investigated in multiple treatment
regimens and in people with co-morbidities.
Daclatasvir is being studied in combination with sofosbuvir 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 III ALLY Program.
In 2014, the U.S. Food and Drug Administration (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 III 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.
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 daclatasvir or any other compounds mentioned in this release
will receive regulatory approval or, if approved, that they will
become commercially successful products. 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.comorCeline
Van DoosselaereOffice: +33 (0)1 5883 6027Cell: +33 (0)6 1477
3431celine.vandoosselaere@bms.comorInvestors:Ranya Dajani, +1
609-252-5330ranya.dajani@bms.comorRyan Asay, +1
609-252-5020ryan.asay@bms.com
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