- MAVIRET is the first and only 8-week treatment approved in Japan
for genotype 1 and 2 hepatitis C virus (HCV) infected patients without
cirrhosis and who are new to DAA treatment*
- Approval is supported by a 99 percent virologic cure**
rate in these patients, who comprise the majority of people living in
Japan with HCV1,2
- Japan has one of the highest rates of HCV infection in the
industrialized world 2,3
- Glecaprevir, one of the two new, direct-acting antivirals (DAAs) in
MAVIRET, is Enanta’s second protease inhibitor being developed and
commercialized by AbbVie
WATERTOWN, Mass.--(BUSINESS WIRE)--Sep. 27, 2017--
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved
AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir), a once-daily,
ribavirin-free treatment for adults with chronic hepatitis C virus (HCV)
infection across all major genotypes (GT1-6). MAVIRET is the first and
only 8-week treatment option in Japan for GT1 and GT2 HCV infected
patients without cirrhosis and who are new to direct-acting antiviral
(DAA) treatment,* including those with chronic kidney disease (CKD).
These patients represent the majority of people living with HCV in Japan.2
In Japan, MAVIRET is also approved as a 12-week option for patients
infected with GT3-6, patients with specific treatment challenges,
including patients with compensated cirrhosis, and those with limited
treatment options such as those not cured with previous DAA treatment.1
Enanta expects to receive a $15 million milestone payment from AbbVie in
the quarter ending December 31, 2017, upon price reimbursement approval
of MAVIRET in Japan.
“With the approval of this new, pan-genotypic treatment, the majority of
the 2 million people infected with HCV in Japan will now be able to be
treated in as little as eight weeks,” stated Jay R. Luly, Ph.D.,
President and CEO, Enanta.
Japan has one of the highest rates of HCV infection in the
industrialized world, with approximately 2 million people living with
the disease, 97 percent of whom are infected with GT1 or GT2 chronic HCV.2,3Japan also has the highest prevalence of liver cancer amongst the
industrialized countries, with chronic hepatitis C and its complications
being the leading causes.4
This approval of MAVIRET is supported by data from the Phase 3 CERTAIN
studies in Japanese patients and supplemented with registrational
studies from AbbVie's global clinical development program for MAVIRET.
With just 8 weeks of treatment, a 99 percent (n=226/229) SVR12
rate was achieved across GT1 and GT2 chronic HCV infected Japanese
patientswithout cirrhosis and who were new to DAA treatment*.1
This high SVR12 rate was achieved in patients with varied
patient and viral characteristics, including those with CKD.1
In patients not cured with previous DAA treatment, a 94 percent
(n=31/33) SVR12 rate was achieved with 12 weeks of treatment.
The most commonly reported adverse reactions were pruritus, headache,
malaise and blood bilirubin increase (none of which had an incidence
greater than 5 percent).1
MAVIRET combines two new, potent# direct-acting antivirals
that target and inhibit proteins essential for the replication of the
hepatitis C virus. The presence of more difficult-to-treat genotypes or
baseline mutations that are commonly associated with resistance have
been shown to have minimal impact on the efficacy of MAVIRET.
Approval of MAVIRET follows priority review, a designation by the
Japanese MHLW granted to certain medicines based on the clinical
usefulness of the treatment and severity of the disease. AbbVie’s
pan-genotypic treatment was also recently granted marketing
authorization by the European Commission and approved by the U.S. Food
and Drug Administration as an 8-week, pan-genotypic treatment for
patients without cirrhosis and who are new to treatment.
*Patients without previous treatment that included
a DAA (direct-acting antiviral) NS3/4A protease inhibitor, NS5A
inhibitor and/or NS5B polymerase inhibitor.
who achieve a sustained virologic response at 12 weeks post treatment
(SVR12) are considered cured of hepatitis C.
on EC50 values of glecaprevir and pibrentasvir against full-length or
chimeric replicons encoding NS3 or NS5A from laboratory strains and
chimeric replicons from clinical isolates.1
About MAVIRET™ (glecaprevir/pibrentasvir) in Japan
MAVIRET™ is approved by the Japanese Ministry of Health, Labour and
Welfare (MHLW), for the treatment of chronic hepatitis C virus (HCV)
infection in adults across all major genotypes (GT1-6). MAVIRET is a
pan-genotypic, once-daily, ribavirin-free treatment that combines
glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir
(40mg), an NS5A inhibitor, dosed once-daily as three oral tablets.
In Japan, MAVIRET is an 8-week treatment option for GT1 and GT2 HCV
infected patients without cirrhosis, including those with chronic kidney
disease (CKD) and those new to DAA (direct-acting antiviral) treatment,*who
comprise the majority of people living with HCV. MAVIRET is also a
12-week option for patients infected with GT3-6 chronic HCV, patients
with specific treatment challenges, including patients with compensated
cirrhosis, and those with limited treatment options such as those not
cured with previous DAA treatment.1
Indication in Japan
Improvement of viremia in chronic hepatitis C or compensated hepatic
Summary of Safety Information
MAVIRET is contraindicated in patients with a history of known
hypersensitivity to the ingredients of MAVIRET, patients with severe
hepatic impairment (Child-Pugh C) and patients being treated with
atazanavir sulfate, atorvastatin calcium hydrate, or rifampin.
Precautions for Use
Positive result for HCV RNA should be confirmed before administering
MAVIRET and decompensated cirrhosis should also be excluded by hepatic
reserve or clinical symptoms.
While HCV viral load is decreased, HBV reactivation in patients who are
chronically infected with HBV or patients who have a history of HBV
infection (HBs-Ag negative and HBc-Ab or HBs-Ab positive) has been
reported after initiation of HCV DAA treatment. Patients should be
evaluated for the presence of HBV infection prior to the treatment with
Glecaprevir is an inhibitor of P-gp, BCRP, and OATP1B1/1B3. Pibrentasvir
is an inhibitor of P-gp, BCRP and OATP1B1. Glecaprevir is a substrate of
P-gp, BCRP, and OATP1B1/1B3. Pibrentasvir is a substrate of P-gp.
Co-administration of MAVIRET with these drugs may result in increased
plasma concentrations of such drugs or increased or decreased plasma
concentrations of MAVIRET, potentially requiring dose adjustment or
The safety of MAVIRET in pregnant women has not been established.
Administration to women who are pregnant or may be pregnant must be
limited to the cases in which the benefits of the treatment are deemed
to outweigh the risks.
Administration to lactating women must be avoided, or breastfeeding must
be avoided when administration to a lactating woman is unavoidable.
Safety and efficacy has not been established in children.
Common adverse reactions included pruritus in 16 subjects (4.8%),
headache in 14 subjects (4.2%), malaise in 10 subjects (3.0%) and blood
bilirubin increased in 8 subjects (2.4%).
Enanta Pharmaceuticals has used its robust, chemistry-driven approach
and drug discovery capabilities to become a leader in the discovery of
small molecule drugs for the treatment of viral infections and liver
diseases. Two protease inhibitors, paritaprevir and glecaprevir,
discovered and developed through Enanta’s collaboration with AbbVie,
have now been approved in jurisdictions around the world as part of
AbbVie’s direct-acting antiviral (DAA) regimens for the treatment of
hepatitis C virus (HCV) infection, including the U.S. marketed regimens
MAVYRET™ (glecaprevir/pibrentasvir) and VIEKIRA PAK®
Royalties and milestone payments from the AbbVie collaboration are
helping to fund Enanta’s research and development efforts, which are
currently focused on the following disease targets: non-alcoholic
steatohepatitis (NASH)/ primary biliary cholangitis (PBC), respiratory
syncytial virus (RSV) and hepatitis B virus (HBV). Please visit www.enanta.com
for more information.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including
statements with respect to the prospects for reimbursement approval and
commercialization of MAVIRET in the Japan. Statements that are not
historical facts are based on management’s current expectations,
estimates, forecasts and projections about Enanta’s business and the
industry in which it operates and management’s beliefs and assumptions.
The statements contained in this release are not guarantees of future
performance and involve certain risks, uncertainties and assumptions,
which are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual results
include: the efforts of AbbVie (our collaborator developing MAVIRET) to
commercialize MAVIRET successfully in the Japan and to obtain regulatory
approvals of the glecaprevir/pibrentasvir (G/P) combination and
commercialize it successfully in other jurisdictions; the regulatory and
marketing efforts of others with respect to competitive treatment
regimens for HCV; regulatory and reimbursement actions affecting
MAVIRET, any competitive regimen, or both; the need to obtain and
maintain patent protection for glecaprevir and avoid potential
infringement of the intellectual property rights of others; and other
risk factors described or referred to in “Risk Factors” in Enanta’s most
recent Form 10-K for the fiscal year ended September 30, 2016 and other
periodic reports filed more recently with the Securities and Exchange
Commission. Enanta cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this release, and Enanta undertakes no
obligation to update or revise these statements, except as may be
required by law.
1 MAVIRET [package insert]. Tokyo, Japan: AbbVie GK.
Yu ML, Chuang WL. Treatment of chronic hepatitis C in Asia: when East
meets West. J Gastroenterol Hepatal. 2009;24(3):336-45
Liu GG, DiBonaventura M, Yuan Y, et al, The burden of illness for
patients with viral hepatitis C: evidence from a national survey in
Japan. Value Health. 2012;15(1 Suppl):565-71
H. Past, Present, and Future of Viral Hepatitis C in Japan. Euroasian
Journal of Hepato-Gastroenterology 6, 49-51 (2016)
View source version on businesswire.com: http://www.businesswire.com/news/home/20170927005552/en/
Source: Enanta Pharmaceuticals, Inc.
Enanta Pharmaceuticals, Inc.
Kari Watson, 781-235-3060