Posted by Michael Wonder on 19 Dec 2016
AbbVie submits new drug application to U.S. FDA for its investigational regimen of glecaprevir/pibrentasvir for the treatment of all major genotypes of chronic hepatitis C
19 December 2016 - AbbVie's investigational regimen was granted breakthrough therapy designation by the FDA for genotype 1 patients not cured with prior direct-acting anti-virals.
AbbVie announced that it has submitted a new drug application to the U.S. FDA for the company's investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for the treatment of chronic hepatitis C virus (HCV).
In Phase 3 clinical studies, eight weeks of therapy with G/P achieved high sustained virologic response (SVR) rates across all major genotypes (GT 1-6) in patients without cirrhosis, which represents the majority of HCV patients. In patients with compensated cirrhosis, high SVR rates were achieved after 12 weeks of therapy. High SVR rates were also achieved in patients with limited treatment options, such as those with severe chronic kidney disease. In historically difficult to treat populations, including those not cured by prior direct-acting anti-viral treatment regimens, high SVR rates were achieved with durations as short as 12 weeks.
