U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral,
Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C
NORTH CHICAGO, Ill., June 13, 2014
NORTH CHICAGO, Ill., June 13, 2014 /PRNewswire/ --AbbVie (NYSE: ABBV)
announced today that the New Drug Application (NDA) for its investigational,
all-oral, interferon-free regimen for the treatment of adult patients with
chronic genotype 1 (GT1) hepatitis C virus (HCV) infection has been accepted
by the U.S. Food and Drug Administration (FDA) and has been granted priority
The NDA was submitted on April 21, 2014 and is supported by data from a large
clinical program including six Phase III studies of more than 2,300 GT1
patients in over 25 countries. The regimen was granted a Breakthrough Therapy
designation by the FDA in May 2013, 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.
In May 2014, AbbVie submitted marketing authorization applications (MAAs) for
regulatory approval in the European Union.
About AbbVie's Investigational HCV Regimen
The AbbVie investigational regimen consists of ABT-450/ritonavir co-formulated
with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without 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
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.
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