- CHMP opinion is a step closer to the
approval of an eight-week regimen of VIEKIRAX + EXVIERA for
previously untreated genotype 1b (GT1b) chronic hepatitis C virus
(HCV) patients with minimal to moderate fibrosis*
- AbbVie’s EMA label expansion is
supported by 98 percent SVR12 rate in patients in the dedicated
Phase 3b GARNET study1
- GT1b is the most common HCV subtype
globally and accounts for approximately 47 percent of the estimated
nine million people infected with chronic HCV in Europe 2,3,4
- Paritaprevir is Enanta’s lead protease
inhibitor and one of the three direct-acting antivirals in VIEKIRAX
+ EXVIERA
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases,
announced today that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has granted a
positive opinion for an eight-week treatment regimen of AbbVie’s
VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA®
(dasabuvir tablets) as an option for previously untreated adult
patients with genotype 1b (GT1b) chronic HCV infection and minimal
to moderate fibrosis.*
VIEKIRAX + EXVIERA is currently approved in the European Union
for use as a 12-week treatment for GT1b chronic HCV-infected
patients without cirrhosis or with compensated cirrhosis.
Paritaprevir is Enanta’s lead protease inhibitor identified within
the ongoing Enanta-AbbVie collaboration and one of the three
direct-acting antivirals in VIEKIRAX + EXVIERA.
Approximately 160 million people worldwide are infected with
HCV, with GT1b being the most common subtype globally.2,5 In
Europe, this subtype accounts for approximately 47 percent of the
estimated nine million people infected with chronic HCV across the
continent.3,4
The CHMP positive opinion is supported by data from the
dedicated Phase 3b GARNET study. Results showed that with eight
weeks of treatment with VIEKIRAX + EXVIERA, 98 percent (n= 160/163)
of previously untreated GT1b chronic HCV infected patients without
cirrhosis achieved sustained virologic response at 12 weeks
post-treatment (SVR12).1 The most commonly reported adverse events,
occurring at rates equal to or greater than 5 percent, were
headache (21 percent), fatigue (17 percent), nasopharyngitis (8
percent), pruritus (8 percent), nausea (6 percent) and asthenia (5
percent).
*When assessing severity of liver disease using non-invasive
methods, additional blood tests improve accuracy and should be
undertaken prior to 8 week treatment in all patients with moderate
fibrosis.
About AbbVie’s GARNET Study1
The Phase 3b GARNET study was a multicenter, open-label,
single-arm study, investigating the safety and efficacy of eight
weeks of treatment with VIEKIRAX + EXVIERA without ribavirin in
treatment-naïve patients with GT1b chronic HCV infection without
cirrhosis.1 The study enrolled 166 patients across 20 sites around
the world. Of the 166 patients enrolled, 163 patients had GT1b
chronic HCV infection without cirrhosis and three patients with
other HCV genotypes were excluded from the efficacy analysis. The
primary endpoint was the percentage of patients who achieved
SVR12.
Two patients experienced post-treatment relapse and one
discontinued due to noncompliance. Less than one percent of
patients experienced serious adverse events or clinically
significant (Grade ≥3) laboratory abnormalities. One patient
discontinued treatment on Day 45 due to an adverse event but
achieved SVR12.
Additional information about the GARNET study can be found on
www.clinicaltrials.gov.
VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the
treatment of genotype 1 (GT1) chronic hepatitis C virus (HCV)
infection, including patients with compensated cirrhosis. VIEKIRAX
is approved in the European Union for the treatment of genotype 4
(GT4) chronic HCV infection.
VIEKIRAX tablets consist of the fixed-dose combination of
paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg
with ombitasvir 25mg (NS5A inhibitor), dosed once daily. EXVIERA
tablets consist of dasabuvir 250mg (non-nucleoside NS5B polymerase
inhibitor) dosed twice daily. VIEKIRAX + EXVIERA is taken with or
without ribavirin (RBV), dosed twice daily based on patient type.
VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV,
except in genotype 1a patients with compensated cirrhosis
(Child-Pugh A), who should take it for 24 weeks with RBV.
EU Indication
VIEKIRAX is indicated in combination with other medicinal
products for the treatment of chronic hepatitis C (CHC) in adults.
EXVIERA is indicated in combination with other medicinal products
for the treatment of CHC in adults.
Important EU Safety Information
Contraindications:
VIEKIRAX + EXVIERA are contraindicated in patients with severe
hepatic impairment (Child-Pugh C). Patients taking ethinyl
estradiol-containing medicinal products must discontinue them and
switch to an alternative method of contraception prior to
initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain
drugs that are sensitive CYP3A substrates or strong inhibitors of
CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate
enzyme inducers. Do not give EXVIERA with certain drugs that are
strong inhibitors of CYP2C8.
Special warnings and precautions for use
VIEKIRAX and EXVIERA are not recommended as monotherapy and
should be used in combination with other medicinal products for the
treatment of hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients
with Cirrhosis
VIEKIRAX and EXVIERA are not recommended in patients with
moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis
should be monitored for signs and symptoms of hepatic
decompensation, including hepatic laboratory testing at baseline
and during treatment.
ALT elevations
Transient elevations of ALT to >5x ULN without concomitant
elevations of bilirubin occurred in clinical trials with VIEKIRAX +
EXVIERA and were more frequent in a subgroup who were using ethinyl
estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirin
Extreme caution must be taken to avoid pregnancy in female
patients and female partners of male patients when VIEKIRAX with or
without EXVIERA is taken in combination with ribavirin, see section
4.6 and refer to the Summary of Product Characteristics for
ribavirin for additional information.
Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or
other glucocorticoids that are metabolized by CYP3A4. A reduction
in colchicine dosage or interruption in colchicine is recommended
in patients with normal renal or hepatic function. VIEKIRAX with or
without EXVIERA is expected to increase exposure of statins so
certain statins need to be discontinued or dosages reduced. Low
dose ritonavir, which is part of VIEKIRAX, may select for PI
resistance in HIV co-infected patients without ongoing
antiretroviral therapy. HIV co-infected patients without
suppressive antiretroviral therapy should not be treated with
VIEKIRAX.
Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX +
EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at
www.ema.europa.eu
Globally, prescribing information varies; refer to the
individual country product label for complete information.
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
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie
is developing as part of its investigational HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the
E.U. and Japan. Royalties and any further milestone payments from
this collaboration will provide 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 approval of
the label expansion for AbbVie’s VIEKIRAX + EXVIERA regimen as an
eight-week treatment in the E. U. for GT1b HCV.. 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 on paritaprevir that is
marketing VIEKIRAX + EXVIERA) to obtain regulatory approval of the
label expansion for VIEKIRAX + EXVIERA in the E.U.; the
development, regulatory and marketing efforts of others with
respect to competitive HCV treatment regimens; 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 Welzel, T. et al. GARNET: High SVR Rates Following Eight-Week
Treatment with Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir for
Patients with HCV Genotype 1b Infection. Presented at the European
Association for the Study of the Liver Special Conference: New
Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure,
Paris, France on September 23-24, 2016.
2 Gower E. et al. Global epidemiology and genotype distribution
of the hepatitis C virus infection. Journal of Hepatology Update:
Hepatitis C, 2014; 61: S45-S57.
3 O'Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS,
Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and
Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1.
Philadelphia, PA: Saunders Elsevier. 2010:1313-1335.
4 Hatzakis A. et al. The state of hepatitis B and C in Europe:
report from the hepatitis B and C summit conference. Journal of
Viral Hepatitis, 2011; 18 (Suppl. 1): 1-16.
5 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin
Microbiol Infect. 2011; 17(2):107-15.
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Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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