NORTH CHICAGO, Ill.,
March 14, 2017 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global biopharmaceutical company,
today announced that priority review has been granted by the
Japanese Ministry of Health, Labour and Welfare (MHLW) for its
investigational, pan-genotypic, ribavirin-free regimen of
glecaprevir/pibrentasvir (G/P) for the treatment of all major
genotypes (GT1-6) of the chronic hepatitis C virus (HCV). This
priority review follows European Medicines Agency (EMA) accelerated
assessment and U.S. Food and Drug Administration (FDA) priority
review designations in December 2016
and January 2017 respectively.
"We will work closely with the Japanese Pharmaceuticals and
Medical Devices Agency (PMDA) as part of our commitment to provide
a potential cure for as many people living with HCV as possible,"
said Michael Severino, M.D.,
executive vice president, research and development and chief
scientific officer, AbbVie. "We are pleased that G/P has now been
recognized as a potential important therapy for people living with
HCV through the receipt of priority review designations by
regulatory authorities in Japan,
the EU and the U.S."
The Japanese MHLW designates priority review to certain
medicines based on the clinical usefulness of the treatment and
severity of the disease. Japan has
one of the highest rates of hepatitis C infection in the
industrialized world, with approximately 1 million people living
with the disease, 99 percent of whom are infected with genotype 1
(GT1) or genotype 2 (GT2).1,2 If approved, G/P may
provide a shorter, eight week treatment duration for GT1 and GT2
patients without cirrhosis, who make up the majority of HCV
patients, and an additional treatment option for genotypes 3-6
patients. G/P is also intended to address the needs of patients
with specific treatment challenges, including those with severe
chronic kidney disease (CKD) and those not cured with previous DAA
(direct-acting antiviral) treatment.
The New Drug Application (NDA) in Japan was supported by data from the Phase 3
CERTAIN studies in Japanese patients and supplemented with
registrational studies in AbbVie's G/P global clinical development
program, which evaluated more than 2,300 patients in 27 countries
across all major HCV genotypes and special populations. Patient
populations studied included GT1-6, those new and experienced to
treatment, those with compensated cirrhosis and without cirrhosis
and patients with specific treatment challenges, including those
with severe CKD, and those not cured with a prior DAA-containing
regimen. The global program was designed to investigate a faster
path to virologic cure* for all major HCV genotypes (GT1-6) and
with the goal of addressing areas of continued unmet need.
In Japan, the NDA for the G/P
regimen was submitted in February
2017.
*Patients with a sustained virologic response at 12
weeks post treatment (SVR12) are considered cured of
hepatitis C.
About AbbVie's G/P Clinical Development Program
AbbVie's glecaprevir/pibrentasvir (G/P) global clinical
development program was designed to investigate a faster path to
virologic cure* for all major HCV genotypes (GT1-6) and with the
goal of addressing treatment areas of continued unmet need. In
Japan, AbbVie studied the G/P
regimen in additional dedicated clinical trials due to patient and
viral characteristics specific to the Japanese HCV patient
population.
G/P is an investigational, pan-genotypic regimen that is being
evaluated as a potential cure in 8 weeks for HCV patients without
cirrhosis and who are new to treatment with direct-acting
antivirals (DAA), who make up the majority of HCV patients. AbbVie
is also studying G/P in patients with specific treatment
challenges, such as genotype 3, patients who were not cured with
previous DAA treatment and those with chronic kidney disease,
including patients on dialysis.
G/P is an investigational, once-daily regimen that combines two
distinct antiviral agents in a fixed-dose combination of
glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir
(120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral
tablets.
Glecaprevir (GLE) was discovered during the ongoing
collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ:
ENTA) for HCV protease inhibitors and regimens that include
protease inhibitors.
G/P 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. Together with its wholly-owned subsidiary, Pharmacyclics,
AbbVie employs approximately 29,000 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," of
AbbVie's 2015 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
Gower, E. Global epidemiology and genotype distribution of
the hepatitis C virus infection. Journal of Hepatology 2014; 61:
S45-S57. Table 2
2 National Center for Global Health and Medicine.
Hepatitis C. Assessed January 2017.
Available from:
http://www.kanen.ncgm.go.jp/cont/010/c_gata.html
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SOURCE AbbVie