NORTH CHICAGO, Ill.,
July 28, 2017 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global biopharmaceutical company,
today announced that the European Commission has granted 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 who are new to
treatment,* who comprise the majority of the 71 million
people living with HCV globally.2,3
"MAVIRET represents an innovation in HCV care as an 8-week,
pan-genotypic option that combines two distinct antiviral agents
and has high efficacy even against most genotypes commonly
associated with resistance to treatment," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie. "This new treatment advancement has the potential to meet
the diverse needs of patients in as short as 8 weeks across
Europe."
MAVIRET is also indicated 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 (GT3) chronic HCV infection.1
MAVIRET is a pan-genotypic treatment approved for use in patients
across all stages of CKD.1
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.
"MAVIRET is an 8-week, pan-genotypic treatment for non-cirrhotic
patients new to treatment with chronic hepatitis C that met all
primary efficacy endpoints in its extensive HCV clinical trial
program, achieving high cure rates," said Stefan Zeuzem, M.D., chief of the department of
medicine at the J.W. Goethe University
Hospital in Frankfurt, Germany.
"MAVIRET offers a new therapy for the majority of HCV patients and
removes many complexities of pre-treatment patient evaluation."
Authorization is supported by 97.5 percent
(n=779/799)† cure** rate with just 8 weeks of
treatment in GT1-6 patients without cirrhosis and who were 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 efficacy of
MAVIRET.
Approval of MAVIRET follows a review under accelerated
assessment by the European Medicines Agency, which is granted to
new medicines of major public health interest. MAVIRET is now
licensed for use in all 28 member states of the European Union, as
well as Iceland, Liechtenstein and Norway. AbbVie's investigational,
pan-genotypic treatment has also been granted accelerated review
designations by other regulatory authorities including the U.S.
Food and Drug Administration and Japanese Ministry of Health,
Labour and Welfare and is not yet approved in those countries.
*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 who are 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.
Glecaprevir (GLE) was discovered during the ongoing
collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ:
ENTA) for HCV protease inhibitors and regimens that include
protease inhibitors.
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, 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 AbbVie
AbbVie is a global, research-driven
biopharmaceutical company committed to developing innovative
advanced therapies for some of the world's most complex and
critical conditions. The company's mission is to use its expertise,
dedicated people and unique approach to innovation to markedly
improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on
Twitter, Facebook or LinkedIn.
For more information, please visit
www.abbvie.com/HCV.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2016 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as 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.
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SOURCE AbbVie