[October 11, 2017] |
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Enanta Announces Data to be Presented on AbbVie's MAVYRET™ (glecaprevir/pibrentasvir) at The Liver Meeting® 2017
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a chemistry-driven
biotechnology company dedicated to creating and developing small
molecule drugs for viral infections and liver diseases, today announced,
that AbbVie will present new data evaluating MAVYRET™
(glecaprevir/pibrentasvir), its once-daily, ribavirin-free treatment for
adults with chronic hepatitis C virus (HCV) infection across all major
genotypes (GT1-6), at the annual meeting of the American Association for
the Study of Liver Diseases (AASLD). Sixteen AbbVie scientific abstracts
have been accepted, including two oral presentations studying the use of
MAVYRET in patients across genotypes (GT1-6) with compensated cirrhosis
and in treatment-naïve patients with genotype 3 (GT3) HCV. These
populations have historically had limited treatment options. A third
oral presentation evaluates adherence to treatment with MAVYRET in the
clinical development program. The Liver Meeting 2017 will take place in
Washington, D.C., from October 20 - 24, 2017.
Researchers will also present data obtained from AbbVie's MAVYRET
clinical program evaluating patients with cardiovascular, metabolic and
renal conditions as well as data on HCV patient preferences.
Select AbbVie clinical presentations include:
MAVYRET Abstracts
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Adherence to Pangenotypic Glecaprevir/Pibrentasvir Treatment and
SVR12 in HCV-Infected Patients:
An Integrated Analysis of the Phase 2/3 Clinical Trial Program
- Abstract 198; Oral Presentation; Monday, October 23, 2017; 4:15 p.m.
ET
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Efficacy and Safety of Glecaprevir/Pibrentasvir for 8 or 12
Weeks in Treatment-Naïve Patients with Chronic HCV Genotype 3: An
Integrated Phase 2/3 Analysis - Abstract 62; Oral
Presentation; Sunday, October 22, 2017; 1:15 p.m. ET
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Efficacy, Safety, and Pharmacokinetics of
Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis
C Virus Infection and Compensated Cirrhosis: An Integrated Analysis
- Abstract 74; Oral Presentation; Sunday, October 22, 2017; 3:15 p.m.
ET
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Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients
Infected with HCV GT1-3 by Renal Impairment Status: A Pooled Analysis
of Two Phase 3 Japanese Trials - Abstract 1179; Poster
Session; Saturday, October 21, 2017; 2:00 - 7:00 p.m. ET
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Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients With
Chronic Hepatitis C Genotypes 1-6 and Recent Drug Use -
Abstract 1182; Poster Session; Saturday, October 21, 2017; 2:00 - 7:00
p.m. ET
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Safety and Efficacy of Glecaprevir/Pibrentasvir in Patients Aged
65 Years or Older With Chronic Hepatitis C: A Pooled Analysis of Phase
2 and 3 Clinical Trials - Abstract 1188; Poster Session;
Saturday, October 21, 2017; 2:00 - 7:00 p.m. ET
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Impact of Hepatitis C Treatment With Glecaprevir + Pibrentasvir
on Patient`s Health-Related Quality of Life: Results From Phase 3
CERTAIN Trials - Abstract 1187; Poster Session; Saturday,
October 21, 2017; 2:00 - 7:00 p.m. ET
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Exposure-Safety Response Relationship for Glecaprevir and
Pibrentasvir in Hepatitis C Virus-Infected Subjects in Phase 2 and 3
Studies - Abstract 1189; Poster Session; Saturday, October 21,
2017; 2:00 - 7:00 p.m. ET
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Exposure-Response Analyses of Virologic Response to Glecaprevir
and Pibrentasvir in HCV Subjects from Phase 2 and 3 Studies -
Abstract 1185; Poster Session; Saturday, October 21, 2017; 2:00 - 7:00
p.m. ET
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Glecaprevir and Pibrentasvir Exposures in Hepatitis C
Virus-Infected Subjects in Phase 2 and 3 Studies - Abstract
1190; Poster Session; Saturday, October 21, 2017; 2:00 - 7:00 p.m. ET
HCV Health Outcomes Abstract
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Assessing Patient Preferences for and Relative Importance of
Features of New Direct Acting Antiviral (DAA) Treatments for Chronic
Hepatitis C Virus (HCV) Infections - Abstract 741; Poster
Session; Friday, October 20, 2017; 8:00 a.m. - 5:30 p.m. ET
The full AASLD 2017 scientific program can be found at www.aasld.org.
About MAVYRET™ (glecaprevir/pibrentasvir) MAVYRET™ is
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of chronic hepatitis C virus (HCV) infection in adults across
all major genotypes (GT1-6). MAVYRET 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, taken with food.
MAVYRET is an 8-week, pan-genotypic option for patients without
cirrhosis and new to treatment, who comprise the majority of people
living with HCV. MAVYRET is also approved as a treatment for patients
with specific treatment challenges, including those GT1 chronic HCV
patients not cured by prior treatment with either a protease inhibitor
or NS5A inhibitor (but not both), and in patients with limited treatment
options, such as those with GT-3 chronic HCV and those with severe
chronic kidney disease (CKD). MAVYRET is a pan-genotypic treatment
approved for use in patients across all stages of CKD.
Full prescribing information can be found here.
Use and Important Safety Information
USE
MAVYRET™ (glecaprevir and pibrentasvir) tablets are a prescription
medicine used to treat adults with chronic (lasting a long time)
hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5, or 6 infection
without cirrhosis or with compensated cirrhosis.
IMPORTANT SAFETY INFORMATION What is the most important
information to know about MAVYRET?
Hepatitis B virus reactivation: Before starting treatment with
MAVYRET, a doctor will do blood tests to check for hepatitis B virus
infection. If people have ever had hepatitis B virus infection, the
hepatitis B virus could become active again during or after treatment of
hepatitis C virus with MAVYRET. Hepatitis B virus becoming active again
(called reactivation) may cause serious liver problems including liver
failure and death. A doctor will monitor people if they are at risk for
hepatitis B virus reactivation during treatment and after they stop
taking MAVYRET.
MAVYRET must not be taken if people:
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Have certain liver problems
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Are taking the medicines:
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atazanavir (Evotaz®, Reyataz®)
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rifampin (Rifadin®, Rifamate®, Rifater®,
Rimactane®)
What should people tell a doctor before taking MAVYRET?
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If they have ever had hepatitis B virus infection, liver problems
other than hep C infection, or any other medical conditions.
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If they are pregnant or plan to become pregnant, or if they are
breastfeeding or plan to breastfeed. It is not known if MAVYRET will
harm a person's unborn baby or pass into breast milk. A doctor should
be consulted about the best way to feed a baby if taking MAVYRET.
About all the medicines they take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. MAVYRET
and other medicines may affect each other. This can cause people to have
too much or not enough MAVYRET or other medicines in their body. This
may affect the way MAVYRET or other medicines work, or may cause side
effects. - A new medicine must not be started without
telling a doctor. A doctor will provide instruction on whether
it is safe to take MAVYRET with other medicines.
What are the common side effects of MAVYRET?
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The most common side effects of MAVYRET are headache and tiredness.
These are not all of the possible side effects of MAVYRET. A doctor
should be notified if there is any side effect that is bothersome or
that does not go away.
This is the most important information to know about MAVYRET. For
more information, people should talk to a doctor or healthcare provider. People
are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
Please see full Prescribing
Information, including the Patient
Information.
About Enanta Enanta Pharmaceuticals has used its robust,
chemistry-driven approach and drug discovery capabilities to become a
leader in the discovery and development 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 treatment with MAVYRET and commercialization of MAVYRET.
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 MAVYRET) to commercialize MAVYRET successfully
and to obtain further 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 MAVYRET, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171011006168/en/
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