NORTH CHICAGO, Ill.,
April 15, 2015 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced that the Japanese
Ministry of Health, Labour and Welfare (MHLW) has granted priority
review for its investigational, two direct-acting antiviral
treatment of ombitasvir/paritaprevir/ritonavir. This all-oral
treatment is interferon (IFN) and ribavirin (RBV)-free and
will be dosed once daily. The MHLW grants priority review to
certain medicines on the basis of clinical usefulness and severity
of the disease, including diseases like hepatitis C, which affects
approximately 1.5 to 2 million people in Japan.1 AbbVie's investigational
hepatitis C treatment was submitted for marketing approval in
Japan in February 2015. The New Drug Application is for
the treatment of patients with genotype 1 (GT1) chronic hepatitis C
virus (HCV) infection and is supported by the Phase 3 GIFT-I study
in Japanese genotype 1b (GT1b) HCV patients.
"AbbVie is pleased that the Japanese MHLW has granted priority
review for our interferon and ribavirin-free, 12-week, two
direct-acting antiviral treatment regimen. This marks another
important advancement in our HCV clinical development program as we
aim to provide our HCV treatment to patients across the world,"
said Scott Brun, M.D., vice
president, pharmaceutical development, AbbVie. "If approved,
AbbVie's HCV treatment holds the potential to be a promising new
treatment option for patients living with this chronic infection in
Japan."
AbbVie studied a two direct-acting antiviral treatment regimen
without RBV in Japan due to
patient and viral characteristics specific to the Japanese
population, including high prevalence of GT1b. In Japan, GT1 is the most common HCV genotype and
accounts for 60 to 70 percent of all patients infected with
HCV.2 Of those patients, about 95 percent are infected
with the GT1b sub-type.2
Additional information about AbbVie's GIFT-I study can be found
on www.clinicaltrials.gov.
About AbbVie's Investigational Two Direct-Acting Antiviral
HCV Treatment
For the treatment of genotype 1 chronic
hepatitis C virus (HCV) infection in Japan, AbbVie's investigational, two
direct-acting antiviral treatment consists of the fixed-dosed
combination of paritaprevir/ritonavir (150/100 mg) with ombitasvir
(25 mg), dosed once daily.
AbbVie's chronic HCV treatment combines two direct-acting
antivirals, each with a distinct mechanism of action that targets
and inhibits specific HCV proteins of the viral replication
process.
About AbbVie's HCV Clinical Development Program in
Japan
AbbVie's HCV
clinical development program in Japan focuses on its investigational, two
direct-acting antiviral treatment and is designed to achieve high
SVR rates in chronic HCV infected patients, including additional
genotypes and patients with compensated cirrhosis.
Paritaprevir was discovered during the ongoing collaboration
between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV
protease inhibitors and regimens that include protease inhibitors.
Paritaprevir has been developed by AbbVie for use in combination
with AbbVie's other investigational medicines for the treatment of
hepatitis C.
Ombitasvir/paritaprevir/ritonavir is an investigational product
and its safety and efficacy have not been established in
Japan.
About AbbVie
AbbVie is a global, research-based
biopharmaceutical company formed in 2013 following separation from
Abbott Laboratories. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to
develop and market advanced therapies that address some of the
world's most complex and serious diseases. AbbVie employs more
than 26,000 people worldwide and markets medicines in more than 170
countries. For further information on the company and its
people, portfolio and commitments, please visit
www.abbvie.com. Follow @abbvie on Twitter or view careers on
our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this
news release may be forward-looking statements for purposes of the
Private Securities Litigation Reform Act of 1995. The words
"believe," "expect," "anticipate," "project" and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those indicated in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry.
Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," in
AbbVie's 2014 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission.
AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
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1 Kohnodai
Hospital. National Center for Global Health and Medicine [cited 20
February 2013]. Available from:
http://www.ncgm.go.jp/center/forpatient_hcv.html
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2
Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10:
553-562.
http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html.
Accessed December 2014
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SOURCE AbbVie