Enanta Announces European Commission Grants AbbVie Marketing Authorization for MAVIRET® (glecaprevir/pibrentasvir) for the
Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
- MAVIRET is a new, 8-week, pan-genotypic treatment for hepatitis C patients without cirrhosis and
who are new to treatment *
- Marketing authorization is supported by a 97.5 percent cure ** rate
across this group of patients 1
- MAVIRET is approved for use in HCV patients who also have chronic kidney disease 1
- Glecaprevir, one of the two new direct-acting antivirals (DAAs) in MAVIRET, 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 European Commission (EC) has granted AbbVie
marketing authorization for MAVIRET® (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic
hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVIRET is a new, 8-week, pan-genotypic treatment for
patients without cirrhosis and new to treatment*, who comprise the majority of the estimated 71 million people worldwide living
with HCV.2,3
MAVIRET is also indicated for patients with specific treatment challenges, including those with compensated cirrhosis across all
major HCV 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.1 MAVIRET is the only pan-genotypic treatment approved for use in
patients across all stages of CKD.1
Following this marketing authorization of MAVIRET in the European Union (E.U.), Enanta expects to receive a $25 million
milestone payment from AbbVie.
“This authorization means that MAVIRET now has the opportunity to address the majority of HCV patients in Europe with a simple,
pan-genotypic, 8-week treatment option, and is also approved for use in patients across all stages of CKD,” stated Jay R. Luly,
Ph.D., President and CEO, Enanta. “We are thrilled to have our second protease inhibitor approved and be part of this exciting new
HCV regimen.”
The approval of MAVIRET is supported by data from eight 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.
EC authorization is supported by data from AbbVie’s registrational studies showing a combined 97.5 percent (n=779/799)† cure**
rate with just 8 weeks of treatment in GT1-6 patients without cirrhosis and new to treatment.1 This high cure rate was
achieved in patients with varied patient and viral characteristics and including those with CKD.1 For compensated
cirrhotic patients, a 98 percent (n=201/205)‡ cure rate was achieved with 12 weeks of treatment.1 For GT3
treatment-experienced patients with or without compensated cirrhosis, a 96 percent (n=66/69) cure rate was achieved with 16 weeks
of treatment.1 In registrational studies for MAVIRET, less than 0.1 percent of patients discontinued treatment due to
adverse reactions.1 The most commonly reported adverse reactions (incidence greater than or equal to 10 percent) were
headache and fatigue.1
MAVIRET combines two new, potent‡‡ direct-acting antivirals that target and inhibit proteins essential for the
replication of the hepatitis C virus. The presence of most genotypes or baseline mutations that are commonly associated with
resistance have been shown to have minimal impact on the efficacy of MAVIRET.
EC authorization follows the European Medicines Agency’s review of MAVIRET under accelerated assessment, which is granted to new
medicines of major public health interest. AbbVie’s MAVIRET treatment is now licensed for use in all 28 member states of the E.U.,
as well as Iceland, Liechtenstein and Norway. AbbVie's investigational, pan-genotypic regimen has also been granted accelerated
review designations by other regulatory authorities, including the U.S. Food and Drug Administration and the Japanese Ministry of
Health, Labour and Welfare.
*Patients without cirrhosis and new to treatment [either treatment-naive or not cured with previous IFN-based treatments
([peg]IFN +/- RBV or SOF/RBV +/- pegIFN)].
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
†Data were pooled from 8-week arms of the ENDURANCE-1 and 3, and SURVEYOR-2 studies.
‡Data were pooled from 12-week GT3 treatment-naive, compensated cirrhotic arm of the SURVEYOR-2 and EXPEDITION-1 studies.
‡‡ Based on EC50 values of glecaprevir and pibrentasvir against full-length or chimeric replicons encoding NS3 or NS5A from
laboratory strains and chimeric replicons from clinical isolates.1
About MAVIRET® (glecaprevir/pibrentasvir)
MAVIRET® is approved in the European Union for the treatment of chronic hepatitis C virus (HCV) infection in adults 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 option for patients without cirrhosis and new to treatment*, who comprise the majority of
people living with HCV. 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.
EU Indication
MAVIRET is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.
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, and 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.
Adverse Reactions
Most common (≥10 %) adverse reactions for MAVIRET were headache and fatigue.
About Enanta
Enanta 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 STATEMENTS
This press release contains forward-looking statements, including statements with respect to the prospects for commercialization of
MAVIRET in the E.U. and the prospects for commercialization regulatory approval for MAVIRET in other jurisdictions. 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 MAVIRET) to
commercialize MAVIRET successfully in the E.U. 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 MAVIRET, 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 MAVIRET® tablets (glecaprevir/pibrentasvir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd.
2 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.
3 World Health Organization. Global Hepatitis Report 2017. http://apps.who.int/iris/bitstream/10665/255016/1/9789241565455-eng.pdf?ua=1.
Investor Contact
Enanta Pharmaceuticals
Carol Miceli, 617-607-0710
cmiceli@enanta.com
or
Media Contact
MacDougall Biomedical Communications
Kari Watson, 781-235-3060
kwatson@macbiocom.com
View source version on businesswire.com: http://www.businesswire.com/news/home/20170728005462/en/