- Major regulatory milestone achieved toward approval
in the European Union
- Final decision from the European Commission expected in the
first quarter of 2015
NORTH CHICAGO, Illinois,
Nov. 21, 2014 /PRNewswire/
-- The European Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has granted positive
opinions for AbbVie's (NYSE: ABBV) investigational, all-oral,
interferon-free treatment of VIEKIRAX™
(ombitasvir/paritaprevir/ritonavir) + EXVIERA™
(dasabuvir) with or without ribavirin (RBV) for patients with
genotype 1 (GT1) and genotype 4 (GT4) chronic hepatitis C virus
(HCV) infection. The European Commission will review the opinions
and make a final decision sometime in the first quarter of
2015.
"The CHMP positive opinions mark an important milestone in our
HCV development program and recognize the potential our treatment
brings to people in Europe living
with this chronic condition," said Michael
Severino, M.D., executive vice president, research and
development and chief scientific officer, AbbVie. "Our treatment
has been developed with the goal of achieving high cure rates in a
broad range of genotype 1 patients with low rates of
discontinuation and relapse."
The marketing authorization applications (MAAs) were submitted
to the EMA on May 6, 2014 under an
accelerated assessment, designated to new medicines of major public
health interest. Review of the MAAs is being conducted under the
centralized licensing procedure, which if approved will result in
marketing authorizations valid in all 28 member states of the
European Union, as well as Iceland, Liechtenstein and Norway.
Robust Clinical Program Supported Positive
Opinions
The CHMP opinions are supported by a robust
clinical development program consisting of six pivotal Phase 3
studies (SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and
TURQUOISE-II)1,2,3,4,5 including more than 2,300 GT1
patients in over 25 countries. In addition, the positive opinions
were supported by a Phase 2 study, PEARL-I, in GT4 patients without
cirrhosis6, as well as preliminary data from the
TURQUOISE-I study in GT1 HCV and HIV-1 co-infected
patients7 and from the CORAL-I study in liver transplant
recipients with recurrent GT1 HCV infection who were new to
treatment after transplantation.8
Approximately nine million people in Europe are infected with HCV, which over time
may lead to cirrhosis and liver failure in about 10-20 percent of
people with chronic HCV.9,10 Genotype 1 is the most
common type of HCV genotype9, accounting for 60 percent
of cases worldwide.10 In Europe, the most prevalent genotype is 1b (47
percent).11 Genotype 4, most common in the
Middle East, sub-Saharan Africa
and Egypt, is becoming
increasingly prevalent in several European countries including
Italy, France, Greece and Spain.12
The U.S. Food and Drug Administration (FDA) granted priority
review for AbbVie's treatment for patients with GT1 chronic HCV
infection on June 13, 2014. AbbVie's
treatment was also granted Breakthrough Therapy designation by the
FDA, a status given to investigational treatments for serious or
life-threatening conditions with preliminary clinical evidence
demonstrating substantial improvement on at least one clinically
significant endpoint compared to available therapy.
About AbbVie's Investigational Chronic HCV
Treatment
VIEKIRAX™ + EXVIERA™ is being investigated for the
treatment of genotype 1 chronic hepatitis C virus (HCV) infection,
including patients with compensated cirrhosis. VIEKIRAX consists of
the fixed-dose combination of paritaprevir 150mg (NS3/4A protease
inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A
inhibitor), dosed once daily, and EXVIERA consists of dasabuvir
250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily,
with or without ribavirin, dosed twice daily.
AbbVie's chronic HCV treatment combines three direct-acting
antivirals, each with a distinct mechanism of action that targets
and inhibits specific HCV proteins of the viral replication
process.
For genotype 4 chronic HCV patients, AbbVie's treatment consists
of the fixed-dose combination of paritaprevir/ritonavir
(150mg/100mg) with ombitasvir (25mg) only, dosed once daily with
ribavirin, dosed twice daily.
Paritaprevir was discovered during the ongoing collaboration
between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV
protease inhibitors and regimens that include protease inhibitors.
Paritaprevir has been developed by AbbVie for use in combination
with AbbVie's other investigational medicines for the treatment of
hepatitis C.
Additional information about AbbVie's HCV development program
can be found on www.clinicaltrials.gov.
About AbbVie
AbbVie is a global, research-based
biopharmaceutical company formed in 2013 following separation from
Abbott Laboratories. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to
develop and market advanced therapies that address some of the
world's most complex and serious diseases. AbbVie employs
approximately 25,000 people worldwide and markets medicines in more
than 170 countries. For further information on the company and
its people, portfolio and commitments, please visit
www.abbvie.com. Follow @abbvie on Twitter or view careers on
our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this
news release may be 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," in
AbbVie's 2013 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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ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin. N Engl J Med.
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ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin. N Engl J Med.
2014; 370:1604-1614
3. Andreone P, Colombo MG, Enejosa JV et al. ABT-450, Ritonavir,
Ombitasvir, and Dasabuvir Achieves 97% and 100% Sustained Virologic
Response With or Without Ribavirin in Treatment-Experienced
Patients With HCV Genotype 1b Infection. Gastroenterology. 2014
Aug;147(2):359-365
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and Dasabuvir with or without Ribavirin for HCV. N Engl J Med.
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and dasabuvir and ribavirin. Presented at the 65th Annual Meeting
of the American Association for the Study of Liver Diseases (The
Liver Meeting 2014), November 7–11, 2014, Boston, MA. Poster #1939
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Organization Web site.
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Published 2003. Accessed November 2014
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Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and
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