Bristol-Myers Squibb Announces Acceptance of New Drug Application for Investigational Daclatasvir for FDA Review for the Trea...
March 12 2015 - 3:00PM
Business Wire
The NDA contains data to support approval
for daclatasvir in combination with sofosbuvir; would be the first
12-week regimen specifically for the treatment of hepatitis C
genotype 3
The application is based on a Phase III
clinical trial which tested a 12-week, ribavirin-free regimen and
resulted in sustained virologic response (SVR12) in 90% of
treatment-naïve and 86% of treatment-experienced genotype 3 HCV
patients
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the
resubmitted new drug application (NDA) for daclatasvir, an
investigational NS5A replication complex inhibitor, has been
accepted for review by the U.S. Food and Drug Administration (FDA)
for use in combination with sofosbuvir for the treatment of chronic
hepatitis C (HCV) genotype 3. The original NDA has been amended to
include data from the Phase III ALLY-3 trial, which showed high
cure rates for the combination, with sustained virologic response
12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86%
of treatment-experienced genotype 3 HCV patients. SVR12 rates were
higher (96%) in non-cirrhotic genotype 3 patients, regardless of
treatment history. The FDA will now review the submission within a
six-month timeframe.
“The daclatasvir-based NDA seeks to address a high-unmet patient
need that still exists despite recent hepatitis C treatment
advances. Approximately 9-12% of HCV patients in the U.S. have
genotype 3. That’s thousands of individuals in the U.S. who
historically have had limited treatment options requiring at least
24 weeks of treatment,” said Douglas Manion, M.D., head of
Specialty Development, Bristol-Myers Squibb. “We also are
continuing clinical trials to determine the potential of
daclatasvir-based regimens in treating a range of other high
unmet-need patients, including those coinfected with HIV, HCV
patients with decompensated cirrhosis, and HCV recurrence in
post-transplant patients.”
Genotype 3 is estimated to affect 54.3 million people worldwide,
and is the second most common hepatitis C genotype after genotype 1
(83.4 million). The more aggressive nature of genotype 3 lies in
the damage it causes to the liver, as it is associated with
progressive disease, increased rates of steatosis and a
disproportionately increased risk of hepatocellular carcinoma.
In the ALLY-3 study, the daclatasvir and sofosbuvir combination
regimen was well tolerated, with no deaths, treatment-related
serious adverse events, or discontinuations due to adverse events.
The most frequent side effects (≥5%) were headache (19.7%), fatigue
(19.1%), nausea (11.8%), diarrhea (8.6%), insomnia (5.9%),
abdominal pain and arthralgia (both 5.3%). Additionally, there were
17 (11.2%) treatment failures, with 16 relapses post-treatment and
1 rebound at the end of treatment. There were no viral
breakthroughs in this ribavirin-free regimen.
About ALLY-3: Study Design
This Phase III open-label clinical trial enrolled 152 genotype 3
HCV patients; 101 treatment-naïve patients and 51
treatment-experienced patients in 2 cohorts each received
daclatasvir 60 mg and sofosbuvir 400 mg once daily for 12 weeks,
with 24 weeks of follow-up. The primary endpoint was SVR12 rates,
defined as HCV RNA < LLOQ target detected or not detected at
follow-up week 12 in treatment-naïve and treatment-experienced
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.
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 20 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, a NS5A
complex inhibitor, which continues to be investigated in multiple
treatment regimens and in people with co-morbidities.
Daclatasvir was approved in Europe in August 2014, and more
recently in Brazil in January 2015, 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.
Daclatasvir also is approved in Japan in combination
with asunaprevir, a NS3/4A protease inhibitor.
The daclatasvir+asunaprevir 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.
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.
Bristol-Myers Squibb CompanyMedia:Robert Perry,
Office: 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 Aug 2024 to Sep 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Sep 2023 to Sep 2024