AbbVie Submits for EU Marketing Authorization its Investigational, All-Oral,
Interferon-Free Therapy for the Treatment of Chronic Hepatitis C
NORTH CHICAGO, Illinois, May 8, 2014
--Submission based on the largest Phase III program in genotype 1 (GT1)
hepatitis C patients conducted to date ^
--European Medicines Agency has granted AbbVie's request for accelerated
NORTH CHICAGO, Illinois, May 8, 2014 /PRNewswire/ --AbbVie (NYSE: ABBV)
submitted marketing authorization applications (MAAs) to the European
Medicines Agency (EMA) seeking approval for the company's investigational,
all-oral, interferon-free regimen for the treatment of adult patients with
chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The MAAs are
supported by data from the largest all-oral, interferon-free clinical program
in GT1 patients conducted to date ^ , which consists of six Phase III
studies that include more than 2,300 patients in over 25 countries.
"These regulatory submissions bring us closer to offering adult genotype 1
chronic hepatitis C patients an all-oral, interferon-free regimen which has
the potential to provide a promising advancement for the hepatitis C community
in the European Union," said Scott Brun, M.D., vice president, Pharmaceutical
Development, AbbVie. "This regulatory milestone, on the heels of our
submission of a New Drug Application in the U.S., represents an important step
for our pipeline."
Accelerated Assessment Granted The EMA has granted AbbVie's request for
accelerated assessment for ABT-450/ritonavir, ombitasvir (ABT-267), and
dasabuvir (ABT-333), a designation that is granted to new medicines of major
public health interest. Review of AbbVie's MAAs will be conducted under the
centralized licensing procedure which, when finalized, provides one marketing
authorization in all 28 member states of the European Union (EU). Although
accelerated assessment could shorten the EMA's review time by approximately
two months, it does not guarantee a positive opinion from the EMA's Committee
for Medicinal Products for Human Use (CHMP) or final approval by the European
Commission. If approved, ABT-450/ritonavir, ombitasvir (ABT-267), and
dasabuvir (ABT-333) could be available for marketing in the EU in the first
quarter of 2015.
Globally, approximately 160 million people are chronically infected with
hepatitis C ^ and an estimated 3 million to 4 million people are newly
infected each year. ^ In Europe, approximately 17.5 million people have
chronic hepatitis C, ^ with GT1 as the predominant genotype. ^
About AbbVie's Investigational HCV Regimen The AbbVie investigational regimen
consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg)
co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir
(ABT-333) 250mg with or without ribavirin (weight-based), dosed twice daily.
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
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 ribavirin 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.
^ Comparison based on review of data from www.clinicaltrials.gov for phase
3a programs of Gilead, BMS and BI as of November 15, 2013. ^ Lavanchy D.
Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011;
17(2):107-15. ^ World Gastroenterology Organisation. World Gastroenterology
Organisation Global Guidelines: Diagnosis, Management and Prevention of
Hepatitis C. April 2013.
. Accessed April 25, 2014. ^ EASL Clinical Practice Guidelines: management
of hepatitis C virus infection. European Association for the Study of the
Liver. J Hepatol . 2014;60:392-420.
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Liz Shea, +1-847-935-2211, firstname.lastname@example.org
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