Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C
April 07 2014 - 08:00AM
Business Wire
U.S. application submission marks third
major daclatasvir regulatory milestone globally, follows E.U. and
Japan
Bristol-Myers Squibb Company (NYSE:BMY) announced today that
they have submitted new drug applications (NDAs) with the U.S. Food
and Drug Administration (FDA) for the investigational products
daclatasvir (DCV), an NS5A replication complex inhibitor, and
asunaprevir (ASV), a NS3 protease inhibitor. The data submitted in
the NDAs support the use of DCV+ASV in patients with genotype 1b
hepatitis C (HCV). The DCV NDA also seeks approval for use of this
compound in combination with other agents for multiple genotypes.
The submissions are subject to FDA review for acceptance for
filing.
“These FDA submissions represent a major step towards offering
daclatasvir-based regimens to U.S. HCV patients, many of whom
continue to have high unmet medical needs,” said Brian Daniels, MD,
senior vice president, Global Development and Medical Affairs,
Research and Development, Bristol-Myers Squibb. “We are excited to
have achieved this milestone and, looking forward, will continue to
innovate and invest in daclatasvir in a range of patient types and
regimens.”
These submissions follow the recent announcement that the FDA
granted the investigational DCV Dual Regimen (DCV+ASV) Breakthrough
Therapy Designation. In 2013, the investigational all-oral 3DAA
Regimen (daclatasvir/asunaprevir/BMS-791325) also received
Breakthrough Therapy Designation, and the company anticipates
submitting this regimen for FDA review in Q1 2015.
In January 2014, the European Medicines Agency (EMA) validated
the company’s marketing authorization application for the use of
DCV in combination with other agents for the treatment of adults
with HCV with compensated liver disease, including genotypes 1, 2,
3, and 4, and this application is under accelerated review. In
addition, NDAs for DCV and ASV are under priority review by Japan’s
Pharmaceutical and Medical Devices Agency for patients with chronic
HCV genotype 1b, classified as either interferon-ineligible
naïve/intolerant or non-responders to interferon and ribavirin.
About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted
through direct contact with infected blood and blood products.
Approximately 170 million people worldwide are infected with
hepatitis C, with an estimated 2.7–3.9 million chronically infected
in the United States. 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,
up to 20 percent of people with chronic hepatitis C will develop
cirrhosis; of those, up to 25 percent may progress to liver
cancer.
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 (DCV), an
investigational NS5A replication complex inhibitor that has been
studied in more than 5,500 patients as part of multiple
direct-acting antiviral (DAA) based combination therapies. DCV
has shown a low drug-drug interaction profile, supporting its
potential use in multiple treatment regimens and in people with
co-morbidities.
DCV is currently being studied in the ongoing Phase III UNITY
Program, where it is being investigated as part of an all-oral 3DAA
Regimen (daclatasvir/asunaprevir/BMS-791325). Study populations
include non-cirrhotic naïve, cirrhotic naïve and previously treated
patients. The 3DAA Regimen is being studied as a
fixed-dose-combination treatment with twice daily dosing.
Daclatasvir is also being investigated 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.
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 clinical trials of these compounds will support regulatory
filings, or that DCV 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 SquibbMedia:Carrie Fernandez,Office:
+1-609-252-4831; Cell:
+1-215-859-2605carrie.fernandez@bms.comorInvestors:Ranya
Dajani, 609-252-5330, ranya.dajani@bms.comRyan Asay, 609-252-5020,
ryan.asay@bms.com
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