|View printer-friendly version|
|Enanta Announces Japanese Ministry of Health, Labour and Welfare Grants Priority Review for AbbVie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C|
“Receiving priority review in the U.S., the E.U. and now
The Japanese MHLW designates priority review to certain medicines based
on the clinical usefulness of the treatment and severity of the disease.
The New Drug Application (NDA) in
*Patients with a sustained virologic response at 12 weeks post-treatment (SVR12) are considered cured of hepatitis C.
About AbbVie’s G/P Clinical Development Program
AbbVie’s glecaprevir/pibrentasvir (G/P) global 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. In
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 with direct-acting antivirals (DAA), who make
up the majority of HCV patients.
G/P is an investigational, once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral tablets.
G/P is an investigational product and its safety and efficacy have not
been established in
Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with
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
1 Gower, E. Global epidemiology and genotype distribution of
the hepatitis C virus infection.