Priority Review Granted to Fixed-Dose Pan-Genotypic HCV Regimen

The NDA submission is supported by data from eight registrational studies
The NDA submission is supported by data from eight registrational studies

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. 

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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.