- 16 HCV abstracts to be presented
including 12 data presentations on the safety and efficacy of
MAVYRET
- MAVYRET is recommended in new AASLD
guidelines as a first line treatment option for 8 weeks in
treatment-naïve non-cirrhotic HCV patients across all genotypes
(GT1-6)
- Glecaprevir, one of the two new,
direct-acting antivirals (DAAs) in MAVYRET, is Enanta’s second
protease inhibitor being developed and commercialized by
AbbVie
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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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 INFORMATIONWhat 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:
- Have certain liver problems
- Are taking the medicines:
- atazanavir (Evotaz®, Reyataz®)
- rifampin (Rifadin®, Rifamate®,
Rifater®, Rimactane®)
What should people tell a doctor before taking
MAVYRET?
- If they have ever had hepatitis B virus
infection, liver problems other than hep C infection, or any other
medical conditions.
- 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?
- 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 EnantaEnanta 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 STATEMENTSThis 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171011006168/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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