NORTH CHICAGO, Ill.,
Jan. 31, 2020 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced that the European
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has recommended a change to the
marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to
shorten once-daily treatment duration from 12 to 8 weeks in
treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV)
patients with genotype (GT) 3 infection. MAVIRET is currently
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* If approved
by the European Commission (EC), MAVIRET will be the only 8-week
treatment option for treatment-naïve chronic HCV patients, without
cirrhosis or with compensated cirrhosis, regardless of
genotype.*
"The HCV treatment pathway can be a complicated journey for the
millions of patients affected by the disease," said Janet Hammond M.D., Ph.D., vice president,
general medicine and virology therapeutic area, AbbVie. "Today's
positive CHMP opinion for MAVIRET moves us further toward our goal
of providing an effective 8-week therapeutic option with the
potential to simplify the treatment journey for the majority of
people living with HCV, regardless of disease genotype."
The CHMP positive opinion is supported by data from the Phase
3b EXPEDITION-8 study, which 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 in these patients and no
patients have discontinued treatment due to adverse events. Adverse
events (frequency >5%) reported in the study include pruritus
(8%), fatigue (9%), headache (8%) and nausea (6%). Six serious
adverse events (2%) occurred during the study, none of which were
deemed to be related to glecaprevir/pibrentasvir. No new safety
signals were identified in this study.2
The Phase 3b EXPEDITION-8 study
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 GT1, 2,
3, 4, 5, and 6 (n=343) patients.2
"Successfully treating people with HCV has historically been
challenging, in part because of the length of the treatment
duration and the need for additional testing to determine the
patient's disease genotype and fibrosis stage to match them with
the most appropriate therapy," said Stefan
Zeuzem, M.D., chief of the department of medicine at the
J.W. Goethe University Hospital in
Frankfurt, Germany. "A clinically
validated HCV therapeutic option that can reduce both the treatment
timeframe and diagnostic burden may help providers treat more
patients and reduce how many are lost to follow-up, ultimately
potentially helping to hasten elimination of the disease
globally."
About the EXPEDITION-8 Study2
EXPEDITION-8 is a single-arm, open-label, Phase 3b study
in treatment-naïve, GT1-6 chronic HCV patients with compensated
cirrhosis (n=343) who received MAVIRET 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 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 and who are new to treatment and for GT1, 2, 4, 5
and 6 patients who are new to treatment with compensated
cirrhosis*. The recommended treatment duration for
treatment-naïve, compensated cirrhotic GT3 HCV
patients is 12 weeks. 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 during the ongoing
collaboration between AbbVie and Enanta Pharmaceuticals 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 and
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 AbbVie
AbbVie is a global, research and
development-based 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, LinkedIn or Instagram.
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, competition from
other products, challenges to intellectual property, 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 2018 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 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 recommended duration of MAVIRET is 12 weeks in liver or
kidney transplant recipients with or without cirrhosis
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