AbbVie Submits for EU Marketing Authorization its Investigational, All-Oral,
Interferon-Free Therapy for the Treatment of Chronic Hepatitis C
- Submission based on the largest Phase III program in genotype 1 (GT1)
hepatitis C patients conducted to date1
- European Medicines Agency has granted AbbVie's request for accelerated
NORTH CHICAGO, Ill., May 8, 2014
NORTH CHICAGO, Ill., 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^1, 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^2 and an estimated 3 million to 4 million people are newly
infected each year.^3 In Europe, approximately 17.5 million people have
chronic hepatitis C,^^4 with GT1 as the predominant genotype.^4
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
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
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.
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
Facebookor LinkedIn page.
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.
^1 Comparison based on review of data from www.clinicaltrials.gov for phase 3a
programs of Gilead, BMS and BI as of November 15, 2013.
^2 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol
Infect. 2011; 17(2):107-15.
^3 World Gastroenterology Organisation. World Gastroenterology Organisation
Global Guidelines: Diagnosis, Management and Prevention of Hepatitis C. April
Accessed April 25, 2014.
^4 EASL Clinical Practice Guidelines: management of hepatitis C virus
infection. European Association for the Study of the Liver. J Hepatol.
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