- If approved, G/P may provide a shorter, eight week, once-daily, ribavirin-free treatment option for the majority of HCV patients without cirrhosis
- AbbVie’s New Drug Submission is supported by data from its global registrational clinical development program across all major HCV genotypes and in patients with specific treatment challenges
MONTREAL , Feb. 1, 2017 /CNW/ – AbbVie, a global biopharmaceutical company, today announced it has submitted a New Drug Submission (NDS), and received priority review from Health Canada, for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes.
If approved, G/P may provide a shorter treatment duration for genotypes 1-6 (GT1-6) in patients without cirrhosis, who make up a large portion of HCV patients in Canada , and an additional treatment option to patients with compensated cirrhosis (Child-Pugh A). G/P is also intended to address the unmet medical needs of patients with specific treatment challenges, including those with severe chronic kidney disease (CKD) and those not cured with previous direct acting antiviral (DAA) treatment.