- MAVYRET is a new, 8-week, pan-genotypic
treatment for hepatitis C patients without cirrhosis and new to
treatment
- FDA approval is supported by an overall
98 percent cure rate (rates ranged between 92-100 percent) in
patients who received the recommended duration of treatment
- MAVYRET is approved for use across all
stages of chronic kidney disease in patients with any of the major
HCV genotypes
- MAVYRET may be used in up to 95 percent
of HCV patients, depending on stage of liver disease and prior
treatment history*
- 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 research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases, today
announced that the U.S. Food and Drug Administration (FDA) approved
AbbVie’s MAVYRET™ (glecaprevir/pibrentasvir), a once-daily,
ribavirin-free treatment for adults with chronic hepatitis C virus
(HCV) infection across all major genotypes (GT1-6). MAVYRET is an
8-week, pan-genotypic treatment for patients without cirrhosis and
new to treatment. Up to 95 percent of HCV patients in the U.S. may
be eligible for treatment with MAVYRET, including patients with
compensated cirrhosis or without cirrhosis, and those with limited
treatment options, such as patients with chronic kidney disease
(CKD).*
Following this approval of MAVYRET in the U.S., Enanta expects
to receive a $40 million milestone payment from AbbVie.
“A majority of the estimated 3.4 million Americans chronically
infected with HCV have not yet been treated for the disease and do
not yet have cirrhosis. The FDA approval of MAVYRET provides them a
new, 8-week treatment option regardless of their HCV genotype,”
stated Jay R. Luly, Ph.D., President and CEO, Enanta. “Our second
protease inhibitor, glecaprevir, is part of this new combination
treatment that has now been approved in the E.U. and the U.S.”
Approximately 3.4 million Americans are chronically infected
with HCV.1 Additionally, HCV is common among people with severe
CKD, with more than 500,000# people in the U.S. estimated to have
both chronic HCV and CKD.2 MAVYRET was designed to deliver a cure**
across all major genotypes and for specific treatment challenges,
such as patients with severe CKD, and GT1 patients not cured by a
NS5A inhibitor or a NS3/4A protease inhibitor (PI) in a
direct-acting antiviral (DAA) treatment, but not both. MAVYRET
combines two new DAAs that target and inhibit proteins essential
for the replication of the hepatitis C virus.
The approval of MAVYRET is supported by data from nine
registrational studies in AbbVie’s clinical development program,
which evaluated more than 2,300 patients in 27 countries across all
major HCV genotypes (GT1-6) and special populations.
AbbVie’s pan-genotypic regimen also was recently granted
marketing authorization by the European Commission, which means it
is now licensed for use in all 28 member states of the European
Union, as well as Iceland, Liechtenstein and Norway.
*Ipsos Healthcare HCV Monitor, 2017. New York, NY: Ipsos in
North America. ©Ipsos 2017, all rights reserved.
**Patients who achieve a sustained virologic response at 12
weeks post treatment (SVR12) are considered cured of hepatitis
C.
#Based on IMS Dx (Oct. 2016) distribution of 15.7% Renal
patients in diagnosed population applied to ~3.4M HCV prevalence
population of all major HCV genotypes
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)
not cured by prior treatment experience with either a protease
inhibitor or an NS5A inhibitor (but not both), and in patients with
limited treatment options, such as those with severe chronic kidney
disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is
approved for use in patients across all stages of CKD with any of
the major HCV genotypes (GT1-6).
Full prescribing information can be found at
www.rxabbvie.com.
Use and Important Safety Information
USEMAVYRET™ (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.
If people cannot afford their medication, they should
contact www.pparx.org for assistance.
About EnantaEnanta 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 also discovered
novel protease inhibitors that have been developed as part of
AbbVie’s hepatitis C virus (HCV) treatment regimens under a
collaboration that now provides Enanta a payment stream, which it
is using to fund its research and development programs. Please
visit www.enanta.com for more information on Enanta’s programs and
pipeline.
FORWARD LOOKING STATEMENTSThis press release contains
forward-looking statements, including statements with respect to
the prospects for commercialization of MAVYRET in the United
States. 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 in the U.S. and to
obtain regulatory approvals of the glecaprevir/pibrentasvir (G/P)
combination and commercialize it successfully in other
jurisdictions; 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.
1 Messina JP, Humphreys I., Flaxman A., et.al. Global
distribution and prevalence of hepatitis C virus genotypes.
Hepatology. 2015;61(1): 77-87 (and supplementary appendix).2 IMS
Health. IMS Dx/LRx. December 2016. (©IMS Health Inc., all rights
reserved).
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version on businesswire.com: http://www.businesswire.com/news/home/20170803006377/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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