- MAVIRET now available in the EU as an 8-week treatment option
for treatment-naïve, chronic hepatitis C virus (HCV) patients
without cirrhosis or with compensated cirrhosis, regardless of
genotype*
- European Commission’s decision makes MAVIRET the only 8-week
treatment regimen indicated for all common HCV genotypes (GT1—6) in
treatment-naïve, chronic HCV patients both without cirrhosis or
with compensated cirrhosis, without the need for HCV genotype
testing
- Glecaprevir, one of the two direct-acting antivirals (DAAs) in
MAVIRET, was discovered by Enanta and developed and commercialized
by AbbVie
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage
biotechnology company dedicated to creating small molecule drugs
for viral infections and liver diseases, today announced that the
European Commission has granted marketing authorization to its HCV
collaboration partner AbbVie for MAVIRET®
(glecaprevir/pibrentasvir) to shorten the once-daily treatment
duration from 12 to 8 weeks in treatment-naïve, compensated
cirrhotic, chronic HCV patients with genotype (GT) 3 infection.
MAVIRET was already indicated as an 8-week, pan-genotypic (GT1-6),
once-daily regimen for treatment-naïve HCV patients without
cirrhosis, and as an 8-week, once-daily regimen for treatment-naïve
GT 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis.1*
“We are pleased with the European Commission’s authorization
which makes MAVIRET the only eight-week treatment regimen indicated
for all common HCV genotypes in treatment-naïve, chronic HCV
patients both without cirrhosis or with compensated cirrhosis,
without the need for HCV genotype testing,” said Jay Luly, Ph.D.,
President and Chief Executive Officer of Enanta Pharmaceuticals.
“Our hope is that a shorter-duration therapeutic option and
simplified pre-treatment requirements will eliminate the need for
extra tests in many cases and allow for faster time-to-treatment
for newly diagnosed patients.”
The EC approval is supported by data from the Phase 3b
EXPEDITION-8 study, which evaluated the safety and efficacy of
MAVIRET in treatment-naïve chronic HCV patients with compensated
cirrhosis across all major genotypes (GT1-6). The results have been
reported for GT 1, 2, 3, 4, 5, and 6 (n=343) patients2 and showed
that with 8 weeks of MAVIRET, 97.7 percent (n=335/343) of GT1- 6
patients achieved a sustained virologic response 12 weeks after
treatment (SVR12) (ITT). For patients with GT3, the SVR12 rate was
95.2% (n= 60/63) (ITT).**
To date, one virologic failure has been reported and no patients
have discontinued treatment due to adverse events. In the study,
most patients that did not achieve SVR12** were lost to follow-up
versus experiencing treatment failure, and no new safety signals
were identified.2
In the WHO European Region, 14 million people are estimated to
be chronically infected with the HCV and many of them are unaware
that they are infected.3 Each year 112,500 people die from
HCV-related liver disease.3
About the EXPEDITION-8 Study2
EXPEDITION-8 was a single-arm, open-label, Phase 3b study in
treatment-naïve, GT1-6 chronic HCV patients with compensated
cirrhosis (n=343) who received MAVIRET treatment for 8 weeks.
The primary efficacy endpoints were SVR12** in patients with
GT1, 2, 4, 5, and 6 in a per-protocol (PP) and intent-to-treat
(ITT) population versus historical SVR12** rates based on the
efficacy of MAVIRET for 12 weeks in treatment-naïve patients with
compensated cirrhosis. The key secondary efficacy endpoints were
the percentages of GT1-6 patients achieving SVR12** in a PP and ITT
population.
Additional information on the clinical trials for MAVIRET is
available at www.clinicaltrials.gov/.
About MAVIRET® (glecaprevir/pibrentasvir)1
MAVIRET is approved in the European Union for the treatment of
chronic hepatitis C virus (HCV) infection in adults, and in
adolescents aged 12 to <18 years, across all major genotypes
(GT1-6). MAVIRET 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.
MAVIRET is an 8-week, pan-genotypic (GT 1-6) option for patients
without cirrhosis or with compensated cirrhosis and who are new to
treatment.* MAVIRET is also approved as a treatment for patients
with specific treatment challenges, including those with
compensated cirrhosis across all major genotypes, and those who
previously had limited treatment options, such as patients with
severe chronic kidney disease (CKD) or those with genotype 3
chronic HCV infection. MAVIRET is a pan-genotypic treatment
approved for use in patients across all stages of CKD.
MAVIRET is contraindicated in patients with severe hepatic
impairment (Child-Pugh C) and is not recommended in patients with
moderate hepatic impairment (Child-Pugh B).
Glecaprevir (GLE) was discovered by Enanta during its ongoing
collaboration with AbbVie for development of HCV protease
inhibitors and HCV treatment regimens that include those protease
inhibitors.
EU Indication
MAVIRET is indicated for the treatment of chronic hepatitis C
virus (HCV) infection in adults and in adolescents aged 12 to
<18 years old.
Important EU Safety Information
Contraindications:
MAVIRET is contraindicated in patients with severe hepatic
impairment (Child-Pugh C). Concomitant use with atazanavir
containing products, atorvastatin, simvastatin, dabigatran
etexilate, ethinyl oestradiol-containing products, strong P-gp and
CYP3A inducers, such as rifampicin, carbamazepine, St. John's wort,
phenobarbital, phenytoin, and primidone.
Special warnings and precautions for use:
Hepatitis B virus reactivation
Cases of hepatitis B virus (HBV) reactivation, some of them
fatal, have been reported during or after treatment with
direct-acting antiviral agents. HBV screening should be performed
in all patients before initiation of treatment.
Hepatic impairment
MAVIRET is not recommended in patients with moderate hepatic
impairment (Child-Pugh B).
Patients who failed a prior regimen containing an NS5A- and/or
an NS3/4A-inhibitor
MAVIRET is not recommended for the re-treatment of patients with
prior exposure to NS3A/4A and/or NS5A-inhibitors.
Use in diabetic patients
Diabetics may experience improved glucose control and potential
symptomatic hypoglycaemia after initiating HCV direct acting
antiviral treatment. Glucose levels should be closely monitored,
particularly within the first 3 months of treatment.
Adverse Reactions
Most common (≥10%) adverse reactions for MAVIRET were headache
and fatigue.
This is not a complete summary of all safety information. See
MAVIRET full summary of product characteristics (SmPC) at
www.ema.europa.eu. Globally, prescribing information varies; refer
to the individual country product label for complete
information.
About Enanta
Enanta is using 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. Enanta’s research and development
efforts have produced clinical candidates for the following disease
targets: respiratory syncytial virus (RSV), non-alcoholic
steatohepatitis (NASH)/primary biliary cholangitis (PBC), hepatitis
B virus (HBV), and human metapneumovirus (hMPV).
Enanta’s research and development activities are funded by
royalties from hepatitis C virus (HCV) products developed under its
collaboration with AbbVie. Glecaprevir, a protease inhibitor
discovered by Enanta and now marketed by AbbVie in numerous
countries as part of its leading treatment for chronic HCV
infection, is sold under the tradenames MAVYRET (U.S.) and MAVIRET
(ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com
for more information.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for AbbVie sales
of Enanta’s licensed products. 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: Enanta’s royalty revenues
are dependent upon the continued success of AbbVie’s
commercialization of its MAVYRET/MAVIRET regimen; the impact of
development, regulatory and marketing efforts of others with
respect to competitive treatments for HCV; reimbursement and
pricing actions affecting MAVYRET/MAVIRET or any competitive
treatment for HCV; Enanta’s need to obtain and maintain patent
protection for its product candidates 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-Q for the fiscal quarter ended
December 31, 2019 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.
* The recommended duration of MAVIRET is 12 weeks in liver or
kidney transplant recipients without cirrhosis or with compensated
cirrhosis.
**Sustained virologic response (SVR12), defined as HCV RNA less
than lower limit of quantification (LLOQ) at 12 weeks after the end
of treatment, was the primary endpoint in all the studies.
1 MAVIRET® tablets (glecaprevir/pibrentasvir) Summary of product
characteristics. Maidenhead, UK. AbbVie, Ltd.
2 Brown RS et al. Glecaprevir/pibrentasvir for 8 weeks in
treatment-naïve patients with chronic HCV genotypes 1–6 and
compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol (2019) the
HCV cure rate. (ref 1)
3 Hepatitis C in the WHO European Region. WHO Fact Sheet July
2019. Available at:
http://www.euro.who.int/__data/assets/pdf_file/0009/377253/Fact-Sheet-Hepatitis-C_2019_ENG.PDF?ua=1
Last accessed February 2020
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200306005195/en/
Media and Investor Jennifer Viera 617-744-3848
jviera@enanta.com
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