NORTH CHICAGO, Illinois,
June 23, 2017 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global biopharmaceutical company,
today announced that the European Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has
granted a positive opinion recommending marketing authorization of
MAVIRET™ (glecaprevir/pibrentasvir), an investigational,
pan-genotypic treatment for adults with chronic hepatitis C virus
(HCV) infection. If approved, MAVIRET will be a once-daily,
ribavirin-free, 8-week option for patients without cirrhosis and
who are new to treatment across all genotypes (GT1-6), who comprise
the majority of people living with HCV.1 The European
Commission will now review the CHMP opinion and a final decision is
expected in Q3 2017.
"MAVIRET represents a new generation of HCV therapy and has the
potential to be a shorter, 8-week option for patients living with
this serious, chronic illness," said Michael Severino, M.D., executive vice
president, research and development and chief scientific officer,
AbbVie. "Today's CHMP positive opinion takes us closer to
delivering on AbbVie's mission to address continued unmet needs by
bringing a new pan-genotypic option to people living with HCV in
Europe."
The CHMP positive opinion is supported by 97.5 percent
(n=807/828) SVR12 rates with 8 weeks of MAVIRET across
GT1-6 chronic HCV infected patients without cirrhosis and who are
new to treatment, with varied patient and viral
characteristics.2 In an integrated analysis (n=2,265),
less than 0.4 percent of patients discontinued
treatment.3 The reported adverse reactions (incidence
greater than or equal to 10 percent) were headache and
fatigue.3 The type and severity of adverse reactions in
patients with cirrhosis were overall comparable to those seen in
patients without cirrhosis.3
"While the HCV treatment landscape has transformed significantly
over recent years, the disease continues to be a global public
health problem and treatment challenges remain," said Stefan Zeuzem, M.D., chief of the department of
medicine at the J.W. Goethe University
Hospital in Frankfurt, Germany.
"In clinical studies, MAVIRET demonstrated high SVR rates across
all genotypes of HCV patients (GT1-6). If approved, MAVIRET
would remove many of the complexities of pre-treatment patient
evaluation and has the potential to help facilitate the care and
management of HCV."
MAVIRET is also intended to be an additional option for patients
with specific treatment challenges. This includes chronic HCV
patients with compensated cirrhosis (Child-Pugh A), and those who
currently have limited treatment options, such as patients with
severe chronic kidney disease, including those on dialysis, and
patients infected with genotype 3.
The marketing authorization application (MAA) for MAVIRET is
under an accelerated assessment by the EMA, which is granted to new
medicines of major public health interest. The MAA evaluation is
conducted under the centralized licensing procedure, and if
approved, will result in a marketing authorization valid in all 28
member states of the European Union, 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 Japanese Ministry of Health,
Labour and Welfare. MAVIRET is an investigational regimen and its
safety and efficacy have not been established.
About MAVIRET™ (glecaprevir/pibrentasvir)
AbbVie's MAVIRET™ (glecaprevir/pibrentasvir) clinical
development program was designed to investigate a pan-genotypic,
once-daily, ribavirin-free treatment with the potential to provide
a faster path to virologic cure** for all major HCV genotypes
(GT1-6) and with the goal of addressing specific treatment
challenges, including compensated cirrhosis (Child-Pugh A), chronic
kidney disease and genotype 3. MAVIRET is being evaluated as a
potential 8-week, pan-genotypic treatment for the majority of
people living with HCV,1 those without cirrhosis and who
are new to treatment,* and regardless of viral and patient
characteristics.
MAVIRET is a fixed-dose combination of two distinct antiviral
agents: glecaprevir (100mg), an NS3/4A protease inhibitor, and
pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three
oral tablets.
Glecaprevir was discovered during the ongoing collaboration
between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV
protease inhibitors and regimens that include protease
inhibitors.
*Patients who are treatment-naive or had prior treatment
experience with 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.
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.
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.
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1
Decisions Resources Group. Hepatitis C virus: disease landscape
& forecast 2016. January
2017.
2 Puoti et al. High SVR rates with 8 and 12 weeks of
pan-genotypic G/P: integrated efficacy analysis of genotype 1–6
patients without cirrhosis. Presented at: 52nd Annual Meeting of
the European Association for the Study of the Liver; April 19-23, 2017; Amsterdam, the Netherlands. Poster
SAT-233.
3 Dufour et al. Safety of Glecaprevir/Pibrentasvir in
Adults With Chronic Genotype 1–6 FRI-238 Hepatitis C Virus
Infection: An Integrated Analysis.