Bristol-Myers Squibb Receives Amended U.S. FDA Breakthrough Therapy Designation for Investigational Daclatasvir-based Hepatit...
May 20 2015 - 9:00AM
Business Wire
Breakthrough Designation for daclatasvir and
sofosbuvir combination is supported by the recently presented
ALLY-1 trial in patients with advanced cirrhosis or recurrent
hepatitis C (HCV) after liver transplant
FDA Designation signifies that high unmet
need still exists among these patient populations despite other
available therapies
This Designation is separate from the FDA’s
ongoing NDA review of a daclatasvir-sofosbuvir regimen for the
treatment of patients with genotype 3 HCV
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the
U.S. Food and Drug Administration (FDA) has amended a previously
granted Breakthrough Therapy Designation for the investigational
daclatasvir and sofosbuvir combination for use in hepatitis C (HCV)
patients. The updated Designation reflects recently presented data
on HCV genotype 1 patients with advanced cirrhosis (Child-Pugh
Class B or C) and those who develop genotype 1 HCV recurrence
post-liver transplant. Breakthrough Therapy Designation requires
preliminary clinical evidence that demonstrates a drug may have
substantial improvement on at least one clinically significant
endpoint over available therapy.
The designation is supported by data from ALLY-1, a Phase III
clinical trial evaluating a 12-week regimen of daclatasvir and
sofosbuvir once-daily with ribavirin for the treatment of patients
with HCV with either advanced cirrhosis or post-liver transplant
recurrence of HCV. Results from ALLY-1 were recently presented at
The International Liver Congress™ 2015, this year’s annual meeting
of the European Association for the Study of the Liver.
“Our daclatasvir clinical development program focuses on
addressing high unmet medical needs still encountered in the
treatment of hepatitis C despite the advent of new therapies,” said
Douglas Manion, M.D., Head of Specialty Development, Bristol-Myers
Squibb. “This Designation recognizes the importance of developing a
new treatment option for post-liver transplant and cirrhotic
patients, who are among the most challenging patient populations to
treat with currently available regimens.”
According to the FDA, Breakthrough Therapy Designation is
intended to expedite the development and review of drugs for
serious or life-threatening conditions. The FDA first granted a
Designation for the daclatasvir and sofosbuvir combination in 2013;
since that time, there have been significant developments in the
field of HCV. That has led the FDA to review, modify, and in some
cases, rescind previously granted HCV-related Designations.
About Hepatitis C
Hepatitis C is a virus that infects the liver. It spreads
through direct contact with infected blood and blood products.
Approximately 170 million people worldwide are infected with
hepatitis C. 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 20 percent may progress to liver cancer.
About Bristol-Myers Squibb in HCV
Bristol-Myers Squibb’s hepatitis C research and clinical
development efforts center on patients with high unmet medical
needs. At the core of its portfolio is daclatasvir, a NS5A complex
inhibitor being investigated in multiple treatment regimens and
patient populations. The Phase III ALLY Trial Program was
established to study the combination of daclatasvir and sofosbuvir
in various HCV high-unmet need patient subtypes, including patients
with HCV genotype 3, pre- and post-transplant patients and HIV/HCV
coinfected patients.
In July 2014, Japan became the first country in the world to
approve the use of a daclatasvir-based regimen for the treatment of
hepatitis C. Since then, daclatasvir-based regimens have been
approved across Europe, as well as numerous other countries in
Central and South America, the Middle East and the Asia-Pacific
region.
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 will receive regulatory approval in the United
States, or if approved, that it will become 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,
2014, 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150520005306/en/
Bristol-Myers Squibb CompanyMedia:Robert Perry,
609-419-5378Cell:
407-492-4616rob.perry@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.com
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Apr 2023 to Apr 2024