- If approved, MAVIRET™ will provide a
shorter, 8-week, pan-genotypic (GT1-6), once-daily treatment option
for the majority of people living with chronic hepatitis C virus
(HCV)
- MAVIRET would also be an additional HCV
treatment option for patients with specific treatment challenges,
such as those with compensated cirrhosis, chronic kidney disease
and genotype 3
- Final European Commission decision
expected Q3 2017
- Glecaprevir is Enanta’s second protease
inhibitor being developed through its collaboration with AbbVie and
is one of the two new direct-acting antivirals (DAAs) in
MAVIRET
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 Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has granted
AbbVie a positive opinion recommending marketing authorization of
MAVIRET™ (glecaprevir/pibrentasvir), an investigational,
pan-genotypic treatment for adults with chronic hepatitis C virus
(HCV) infection. If approved, MAVIRET will be a once-daily,
ribavirin-free, 8-week treatment option for HCV patients across all
genotypes (GT1-6) without cirrhosis and new to treatment, who
comprise the majority of people living with HCV.1 The European
Commission will now review the CHMP opinion and a final decision is
expected in the next quarter. Glecaprevir is Enanta’s second
protease inhibitor being developed through its collaboration with
AbbVie and is one of the two new direct-acting antivirals (DAAs)
combined in MAVIRET.
The CHMP positive opinion is supported by 97.5 percent
(n=807/828) SVR12 rates with 8 weeks of MAVIRET across GT1-6
chronic HCV-infected patients without cirrhosis and new to
treatment, with varied patient and viral characteristics.2 In an
integrated analysis (n=2,265), less than 0.4 percent of patients
discontinued treatment.3 The reported adverse reactions (incidence
greater than or equal to 10 percent) were headache and fatigue.3
The type and severity of adverse reactions in patients with
cirrhosis were comparable overall to those seen in patients without
cirrhosis.3
“HCV is a global health problem and MAVIRET has the potential to
address the majority of patients with a simple 8-week treatment
option,” stated Jay R. Luly, Ph.D., President and CEO, Enanta. “We
are pleased to have our second protease inhibitor be part of this
exciting new HCV regimen.”
MAVIRET is also intended to be an additional option for patients
with specific treatment challenges. These include chronic HCV
patients with compensated cirrhosis (Child-Pugh A), and those who
currently have limited treatment options, such as patients with
severe chronic kidney disease, including those on dialysis, and
patients infected with genotype 3.
The marketing authorization application (MAA) for MAVIRET is
under an accelerated assessment, which is granted by the EMA to new
medicines of major public health interest. The MAA evaluation is
conducted under the European Union’s centralized licensing
procedure, and if approved will result in a marketing authorization
valid in all 28 member states of the European Union, as well as
Iceland, Liechtenstein and Norway. It would then be subject to
separate reimbursement approvals in each of the member states.
AbbVie’s investigational, pan-genotypic combination of
glecaprevir/pibrentasvir has also been granted priority review
designations by the U.S. Food and Drug Administration and Japanese
Ministry of Health, Labour and Welfare. MAVIRET is an
investigational regimen and its safety and efficacy have not been
established by any regulatory approval.
About MAVIRET™ (glecaprevir/pibrentasvir)
AbbVie’s MAVIRET™ (glecaprevir/pibrentasvir) clinical
development program was designed to investigate a pan-genotypic,
once-daily, ribavirin-free treatment with the potential to provide
a faster path to virologic cure** for all major HCV genotypes
(GT1-6) and with the goal of addressing specific treatment
challenges, including compensated cirrhosis (Child-Pugh A), chronic
kidney disease and genotype 3. MAVIRET is being evaluated as a
potential 8-week, pan-genotypic treatment for the majority of
people living with HCV,1 namely those without cirrhosis and new to
treatment,* and regardless of viral and patient
characteristics.
MAVIRET is a fixed-dose combination of two distinct antiviral
agents: glecaprevir (100mg), an NS3/4A protease inhibitor, and
pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three
oral tablets.
*Patients who are treatment-naive or had prior treatment
experience with 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.
About Enanta
Enanta 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 discovered novel protease inhibitors for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir,
currently marketed in AbbVie’s HCV regimens, and glecaprevir,
Enanta’s second protease inhibitor product, which AbbVie is
developing as part of its investigational, pan-genotypic HCV
regimen of glecaprevir/pibrentasvir, or MAVIRET™, now under
accelerated assessment by the EMA. This combination has also been
granted priority review designation by regulatory agencies in the
U.S. and Japan. Royalties and any further milestone payments from
this collaboration will provide additional funding for Enanta’s
earlier development programs, including its Phase 1 FXR agonist
program for NASH/PBC, and its preclinical programs for HBV and RSV.
Please visit www.enanta.com for more information on Enanta’s
programs and pipeline.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements,
including statements with respect to the prospects for
commercialization regulatory approval for MAVIRET. 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 obtain
regulatory approvals of the glecaprevir/pibrentasvir (G/P)
combination and commercialize it successfully; 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.
______________________________
1Decisions Resources Group. Hepatitis C virus: disease landscape
& forecast 2016. January 2017
2Puoti et al. High SVR rates with 8 and 12 weeks of
pan-genotypic G/P: integrated efficacy analysis of genotype 1–6
patients without cirrhosis. Presented at: 52nd Annual Meeting of
the European Association for the Study of the Liver; April 19-23,
2017; Amsterdam, the Netherlands. Poster SAT-233.
3Dufour et al Safety of Glecaprevir/Pibrentasvir in Adults With
Chronic Genotype 1–6 FRI-238 Hepatitis C Virus Infection: An
Integrated Analysis
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170623005256/en/
InvestorsCarol Miceli,
617-607-0710cmiceli@enanta.comorMediaMacDougall Biomedical
CommunicationsKari Watson, 781-235-3060kwatson@macbiocom.com
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