NORTH CHICAGO, Ill.,
Sept. 30, 2016 /PRNewswire/
-- AbbVie (NYSE: ABBV), a global biopharmaceutical company,
today announced that the U.S. Food and Drug Administration (FDA)
has granted Breakthrough Therapy Designation (BTD) for the
investigational, pan-genotypic regimen of glecaprevir
(ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of
patients with chronic hepatitis C virus (HCV) who failed previous
therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1),
including therapy with an NS5A inhibitor and/or protease
inhibitor.
The BTD is supported by positive results seen in AbbVie's Phase
2 MAGELLAN-1 clinical study. According to the FDA, BTD is intended
to expedite the development and review of therapies for serious or
life threatening conditions.1
"AbbVie is committed to advancing HCV care and addressing areas
of continued unmet need for people living with chronic HCV," said
Michael Severino, M.D., executive
vice president, research and development and chief scientific
officer, AbbVie. "The FDA's Breakthrough Therapy Designation is an
important step in our effort to bring our pan-genotypic regimen to
market, which we are also investigating as an eight week path to
virologic cure for the majority of patients."
AbbVie will present new Phase 3 data evaluating the safety and
efficacy of G/P across all major HCV genotypes (genotypes 1-6) at
an upcoming scientific congress. Additional information on the
clinical trials for G/P is available at www.clinicaltrials.gov.
About AbbVie's Clinical Development Program
AbbVie's HCV clinical development program is intended to advance
scientific knowledge and clinical care of people with chronic HCV
infection by investigating a pan-genotypic (genotypes 1-6) regimen
of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P). G/P is
currently in Phase 3 of clinical development.
AbbVie's investigational regimen includes glecaprevir (GLE), an
NS3/4A protease inhibitor, and pibrentasvir (PIB), an NS5A
inhibitor dosed once daily as three oral tablets.
GLE was discovered during the ongoing collaboration between
AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease
inhibitors and regimens that include protease inhibitors.
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. Together
with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs
more than 28,000 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," of
AbbVie's 2015 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 U.S. Food and Drug Administration. Fact Sheet:
Breakthrough Therapies.
http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm.
Accessed September 1, 2016.
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SOURCE AbbVie