- 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
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.2,3 Japan 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 patients without 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.**Patients who achieve a sustained
virologic response at 12 weeks post treatment (SVR12) are
considered cured of hepatitis C.#Based 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 cirrhosis C.
Summary of Safety Information
Contraindications
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 MAVIRET.
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 clinical monitoring.
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.
Adverse Reactions
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%).
About Enanta
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®
(paritaprevir/ritonavir/ombitasvir/dasabuvir).
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.2 Yu ML,
Chuang WL. Treatment of chronic hepatitis C in Asia: when East
meets West. J Gastroenterol Hepatal. 2009;24(3):336-453 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):565-714 Yatsuhashi, H. Past,
Present, and Future of Viral Hepatitis C in Japan. Euroasian
Journal of Hepato-Gastroenterology 6, 49-51 (2016)
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version on businesswire.com: http://www.businesswire.com/news/home/20170927005552/en/
Investors:Enanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia:MacDougall Biomedical
CommunicationsKari Watson, 781-235-3060kwatson@macbiocom.com
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