NORTH CHICAGO, Illinois,
June 17, 2014 /PRNewswire/ -- AbbVie
(NYSE: ABBV) announced today that the Marketing Authorization
Applications (MAAs) for its investigational, all-oral,
interferon-free regimen for the treatment of adult patients with
chronic genotype 1 (GT1) hepatitis C virus (HCV) infection have
been validated and are under accelerated assessment by the European
Medicines Agency (EMA).
Accelerated assessment, which is designated to new medicines of
major public health interest, was granted by the EMA for AbbVie's
investigational HCV regimen in May. Validation of the MAAs confirms
that the submissions are complete and starts the EMA's centralized
review process. If approved, AbbVie's regimen could be available
for marketing in the European Union (EU) in the first quarter of
2015.
The MAAs were submitted on May 8,
2014 and are supported by data from a large clinical program
including six Phase III studies of more than 2,300 GT1 patients in
over 25 countries. Review of the MAAs will be conducted under the
centralized licensing procedure, which, when finalized, provides
marketing authorizations in all 28 member states of the EU.
On June 13, AbbVie announced that
the New Drug Application (NDA) for AbbVie's regimen was accepted
and granted priority review by the U.S. Food and Drug
Administration (FDA).
About AbbVie's Investigational HCV Regimen
The AbbVie
investigational regimen consists of the fixed-dose combination of
ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and
dasabuvir (ABT-333) with or without ribavirin (RBV). The
combination of three different mechanisms of action interrupts the
hepatitis C virus replication process with the goal of optimizing
sustained virologic response rates across different patient
populations.
Additional information about AbbVie's Phase III studies can be
found on www.clinicaltrials.gov.
AbbVie's HCV Development Program
The AbbVie HCV
clinical development program is intended to advance scientific
knowledge and clinical care by investigating an interferon-free,
all-oral regimen with and without RBV with the goal of producing
high sustained virologic response rates in as many patients as
possible, including those that typically do not respond well to
treatment, such as previous non-responders to interferon-based
therapy or patients with advanced liver fibrosis or cirrhosis.
ABT-450 was discovered during the ongoing collaboration between
AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C
virus protease inhibitors and regimens that include protease
inhibitors. ABT-450 is being developed by AbbVie for use in
combination with AbbVie's other investigational medicines for the
treatment of hepatitis C.
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.