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.