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
HCV Health Outcomes Abstract
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:
What should people tell a doctor before 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?
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.
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Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
[email protected]
or
Media
Contact
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