- MAVIRET is a new, 8-week, pan-genotypic
treatment for hepatitis C patients without cirrhosis and who are
new to treatment *
- Marketing authorization is supported by
a 97.5 percent cure** rate across this group of patients1
- MAVIRET is approved for use in HCV
patients who also have chronic kidney disease1
- 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 European Commission (EC) has granted AbbVie
marketing authorization for 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 a new, 8-week, pan-genotypic treatment for
patients without cirrhosis and new to treatment*, who comprise the
majority of the estimated 71 million people worldwide living with
HCV.2,3
MAVIRET is also indicated for patients with specific treatment
challenges, including those with compensated cirrhosis across all
major HCV genotypes, and those who previously had limited treatment
options, such as patients with severe chronic kidney disease (CKD)
or those with genotype 3 chronic HCV infection.1 MAVIRET is the
only pan-genotypic treatment approved for use in patients across
all stages of CKD.1
Following this marketing authorization of MAVIRET in the
European Union (E.U.), Enanta expects to receive a $25 million
milestone payment from AbbVie.
“This authorization means that MAVIRET now has the opportunity
to address the majority of HCV patients in Europe with a simple,
pan-genotypic, 8-week treatment option, and is also approved for
use in patients across all stages of CKD,” stated Jay R. Luly,
Ph.D., President and CEO, Enanta. “We are thrilled to have our
second protease inhibitor approved and be part of this exciting new
HCV regimen.”
The approval of MAVIRET is supported by data from eight
registrational studies in AbbVie’s clinical development program,
which evaluated more than 2,300 patients in 27 countries across all
major HCV genotypes (GT1-6) and special populations.
EC authorization is supported by data from AbbVie’s
registrational studies showing a combined 97.5 percent (n=779/799)†
cure** rate with just 8 weeks of treatment in GT1-6 patients
without cirrhosis and new to treatment.1 This high cure rate was
achieved in patients with varied patient and viral characteristics
and including those with CKD.1 For compensated cirrhotic patients,
a 98 percent (n=201/205)‡ cure rate was achieved with 12 weeks of
treatment.1 For GT3 treatment-experienced patients with or without
compensated cirrhosis, a 96 percent (n=66/69) cure rate was
achieved with 16 weeks of treatment.1 In registrational studies for
MAVIRET, less than 0.1 percent of patients discontinued treatment
due to adverse reactions.1 The most commonly reported adverse
reactions (incidence greater than or equal to 10 percent) were
headache and fatigue.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 most genotypes or baseline
mutations that are commonly associated with resistance have been
shown to have minimal impact on the efficacy of MAVIRET.
EC authorization follows the European Medicines Agency’s review
of MAVIRET under accelerated assessment, which is granted to new
medicines of major public health interest. AbbVie’s MAVIRET
treatment is now licensed for use in all 28 member states of the
E.U., as well as Iceland, Liechtenstein and Norway. AbbVie's
investigational, pan-genotypic regimen has also been granted
accelerated review designations by other regulatory authorities,
including the U.S. Food and Drug Administration and the Japanese
Ministry of Health, Labour and Welfare.
*Patients without cirrhosis and new to treatment [either
treatment-naive or not cured with previous IFN-based treatments
([peg]IFN +/- RBV or SOF/RBV +/- pegIFN)].**Patients who achieve a
sustained virologic response at 12 weeks post treatment (SVR12) are
considered cured of hepatitis C.†Data were pooled from 8-week arms
of the ENDURANCE-1 and 3, and SURVEYOR-2 studies.‡Data were pooled
from 12-week GT3 treatment-naive, compensated cirrhotic arm of the
SURVEYOR-2 and EXPEDITION-1 studies.‡‡ 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)MAVIRET® is
approved in the European Union 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.
MAVIRET is an 8-week, pan-genotypic option for patients without
cirrhosis and new to treatment*, who comprise the majority of
people living with HCV. MAVIRET is also approved as a treatment for
patients with specific treatment challenges, including those with
compensated cirrhosis across all major genotypes, and those who
previously had limited treatment options, such as patients with
severe chronic kidney disease (CKD) or those with genotype 3
chronic HCV infection. MAVIRET is a pan-genotypic treatment
approved for use in patients across all stages of CKD.
EU IndicationMAVIRET is indicated for the treatment of
chronic hepatitis C virus (HCV) infection in adults.
Important EU Safety
InformationContraindications:MAVIRET is contraindicated
in patients with severe hepatic impairment (Child-Pugh C).
Concomitant use with atazanavir-containing products, atorvastatin,
simvastatin, dabigatran etexilate, ethinyl oestradiol-containing
products, and strong P-gp and CYP3A inducers, such as rifampicin,
carbamazepine, St. John’s wort, phenobarbital, phenytoin, and
primidone.
Special warnings and precautions for use:Hepatitis B
virus reactivationCases of hepatitis B virus (HBV) reactivation,
some of them fatal, have been reported during or after treatment
with direct-acting antiviral agents. HBV screening should be
performed in all patients before initiation of treatment.
Hepatic impairmentMAVIRET is not recommended in patients with
moderate hepatic impairment (Child Pugh-B).
Patients who failed a prior regimen containing an NS5A- and/or
an NS3/4A-inhibitorMAVIRET is not recommended for the re-treatment
of patients with prior exposure to NS3A/4A and/or
NS5A-inhibitors.
Adverse ReactionsMost common (≥10 %) adverse reactions
for MAVIRET were headache and fatigue.
About EnantaEnanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases.
Enanta’s research and development efforts 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). Enanta has also discovered
novel protease inhibitors that have been developed as part of
AbbVie’s hepatitis C virus (HCV) treatment regimens under a
collaboration that now provides Enanta a payment stream, which it
is using to fund its research and development programs. Please
visit www.enanta.com for more information on Enanta’s programs and
pipeline.
FORWARD LOOKING STATEMENTSThis press release contains
forward-looking statements, including statements with respect to
the prospects for commercialization of MAVIRET in the E.U. and the
prospects for commercialization regulatory approval for MAVIRET in
other jurisdictions. 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 E.U. 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® tablets (glecaprevir/pibrentasvir) Summary of product
characteristics. Maidenhead, UK. AbbVie, Ltd.2 Decisions Resources
Group. Hepatitis C virus: disease landscape & forecast 2016.
January 2017.3 World Health Organization. Global Hepatitis Report
2017.
http://apps.who.int/iris/bitstream/10665/255016/1/9789241565455-eng.pdf?ua=1.
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version on businesswire.com: http://www.businesswire.com/news/home/20170728005462/en/
Investor ContactEnanta PharmaceuticalsCarol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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