If approved, G/P may provide an eight-week, once-daily,
ribavirin-free cure* for HCV patients new to treatment who have any of
the major HCV genotypes, without cirrhosis
G/P includes Enanta’s second protease inhibitor, glecaprevir
WATERTOWN, Mass.--(BUSINESS WIRE)--Feb. 2, 2017--
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today announced
that the U.S. Food and Drug Administration (FDA) has accepted AbbVie’s
New Drug Application (NDA) for its investigational, pan-genotypic
regimen of glecaprevir/pibrentasvir (G/P) being evaluated for the
treatment of all major genotypes (GT1-6) of chronic hepatitis C virus
(HCV), and has granted the NDA priority review. Glecaprevir is Enanta’s
second protease inhibitor being developed through its collaboration with
AbbVie and is one of the two new direct-acting antivirals in G/P.
The FDA grants priority review designation to medicines that it
determines have the potential to provide significant improvements in the
safety and effectiveness of the treatment of a serious disease. The NDA
is supported by data from eight registrational studies in AbbVie's G/P
clinical development program, which evaluated more than 2,300 patients
in 27 countries across major HCV genotypes and special populations.
About AbbVie’s G/P HCV Clinical Development Program
AbbVie’s glecaprevir/pibrentasvir (G/P) clinical development program was
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing treatment areas of
continued unmet need.
G/P is an investigational, pan-genotypic regimen that is being evaluated
as a potential cure in 8 weeks for HCV patients without cirrhosis and
who are new to treatment, who make up the majority of HCV patients.
AbbVie is also studying G/P in patients with specific treatment
challenges, such as genotype 3 HCV patients, patients who were not cured
with previous DAA treatment, and patients with chronic kidney disease
(CKD), including patients on dialysis.
G/P is a once-daily regimen that combines two distinct antiviral agents
in a fixed-dose combination of glecaprevir (100mg), an NS3/4A protease
inhibitor, and pibrentasvir (40mg), an NS5A inhibitor. G/P (300/120mg)
is dosed once-daily as three oral tablets.
Additional information on AbbVie’s clinical trials for G/P is available
*Patients who achieve a sustained virologic response at 12 weeks post
treatment (SVR12) are considered cured of hepatitis C.
Enanta Pharmaceuticals is a research and development-focused
biotechnology company that uses its robust chemistry-driven approach and
drug discovery capabilities to create small molecule drugs for viral
infections and liver diseases. Enanta’s research and development efforts
are currently focused on the following disease targets: non-alcoholic
steatohepatitis (NASH)/ primary biliary cholangitis (PBC), respiratory
syncytial virus (RSV) and hepatitis B virus (HBV).
Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, currently
marketed in AbbVie’s HCV regimens, and glecaprevir (ABT-493), Enanta’s
second protease inhibitor product, which AbbVie is developing as part of
its investigational HCV regimen of glecaprevir/pibrentasvir (G/P)
currently under regulatory review in the U.S. and the E.U. Royalties and
any further milestone payments from this collaboration will provide
funding for Enanta’s earlier development programs, including its Phase 1
FXR agonist program for NASH/PBC, and its preclinical programs for HBV
and RSV. Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s G/P regimen for
HCV. Statements that are not historical facts are based on management’s
current expectations, estimates, forecasts and projections about
Enanta’s business and the industry in which it operates and management’s
beliefs and assumptions. The statements contained in this release are
not guarantees of future performance and involve certain risks,
uncertainties and assumptions, which are difficult to predict.
Therefore, actual outcomes and results may differ materially from what
is expressed in such forward-looking statements. Important factors and
risks that may affect actual results include: the efforts of AbbVie (our
collaborator developing glecaprevir) to obtain regulatory approvals of
its glecaprevir/pibrentasvir (G/P) combination and commercialize it
successfully; the regulatory and marketing efforts of others with
respect to competitive treatment regimens for HCV; regulatory and
reimbursement actions affecting G/P, any competitive regimen, or both;
the need to obtain and maintain patent protection for glecaprevir and
avoid potential infringement of the intellectual property rights of
others; and other risk factors described or referred to in “Risk
Factors” in Enanta’s most recent Form 10-K for the fiscal year ended
September 30, 2016 and other periodic reports filed more recently with
the Securities and Exchange Commission. Enanta cautions investors not to
place undue reliance on the forward-looking statements contained in this
release. These statements speak only as of the date of this release, and
Enanta undertakes no obligation to update or revise these statements,
except as may be required by law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170202005659/en/
Source: Enanta Pharmaceuticals, Inc.
Enanta Pharmaceuticals, Inc.
MacDougall Biomedical Communications