FDA Grants Priority Review to Fixed-Dose Pan-Genotypic HCV Regimen
AbbVie submitted the NDA based on 8 registrational studies in its glecaprevir/pibrentasvir clinical development program.
The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) of glecaprevir/pibrentasvir (G/P; AbbVie) for the treatment of genotypes 1-6 (GT1-6) chronic hepatitis C virus (HCV) infection.
The NDA submission is supported by data from eight registrational studies in the G/P clinical development program, which evaluated the fixed-dose regimen in more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6), including special populations.
The studies evaluated G/P as a potential ribavirin-free cure, defined as achieving a sustained virologic response at 12 weeks post treatment (SVR12), for HCV infection in 8 weeks for treatment-naïve patients without cirrhosis. Additional trials are ongoing for the G/P regimen, including studies in patients with specific treatment challenges (eg, genotype 3), failure to previous DAA treatment and CKD patients.
G/P is an investigational, fixed-dose (300/120mg), once-daily, pan-genotypic regimen consisting of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, NS5A inhibitor.
For more information call (800) 633-9110 or visit Abbvie.com.
U.S. FDA grants priority review to AbbVie for its investigational regimen of glecaprevir/pibrentasvir (G/P) for the treatment of chronic hepatitis C in all major genotypes (GT1-6) [press release]. North Chicago, IL: AbbVie Inc. Published February 2, 2017. Accessed February 13, 2017.