AbbVie Submits New Drug Application to U.S. FDA for its Investigational,
All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C
-Submission based on the largest Phase III program in genotype 1 (GT1)
hepatitis C patients conducted to date(1)
-AbbVie's investigational regimen was designated as a Breakthrough Therapy by
-AbbVie plans to submit applications for regulatory approval of its regimen in
the European Union in early May
NORTH CHICAGO, Ill., April 22, 2014
NORTH CHICAGO, Ill., April 22, 2014 /PRNewswire/ --AbbVie (NYSE: ABBV)
submitted its New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) 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 NDA is
supported by data from the largest all-oral, interferon-free clinical program
in GT1 patients conducted to date,^1 with six Phase III studies that included
more than 2,300 patients in over 25 countries.
"This NDA submission is a significant advancement for AbbVie's HCV development
program," said Scott Brun, M.D., vice president, Pharmaceutical Development,
AbbVie. "Based on the robust data that have been generated in our
international Phase III HCV program, we believe our all-oral, interferon-free
regimen holds the potential to be a promising new therapy for patients living
with this chronic infection."
In May of 2013, AbbVie's investigational direct-acting antiviral (DAA) regimen
with and without ribavirin for HCV genotype 1 was designated as a Breakthrough
Therapy by the U.S. FDA. This designation is intended to help expedite the
development of drugs for serious or life-threatening conditions and is based
in part on preliminary clinical evidence demonstrating a drug or regimen may
have substantial improvement on at least one clinically significant endpoint
compared to available therapy.
AbbVie plans to submit applications for regulatory approval of its regimen in
the European Union in early May.
In the U.S., an estimated 3.2 million people are living with HCV and the
infection is most prevalent among those born between 1945 and 1965.^2
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 RBV
(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
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.govfor phase 3a
programs of Gilead, BMS and BI as of November 15, 2013.
^2 Centers for Disease Control and Prevention. Hepatitis C FAQs for Health
Professionals. 2013. http://www.cdc.gov/hepatitis/HCV/HCVfaq.htm#section1.
Accessed March 14, 2014.
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