AbbVie filed a New Drug Application (NDA) with FDA today, for its all-oral HCV combo drug in adults with chronic genotype 1 HCV infection. The regimen consists of ABT-450/ritonavir, ombitasvir (ABT-267) and dasabuvir (ABT-333).
The investigational drug combo has demonstrated SVR12 (cure) rates of over 95% in trials.
AbbVie’s VP, Pharmaceutical Development, Scott Brun, said in a statement: “Based on the robust data that have been generated in our international Phase-III HCV program, we believe an all-oral, interferon-free regimen holds the potential to be a promising new therapy for patients living with the chronic infection.”
The regimen’s application is supported by data from six Phase-III studies spanning over 2,300 patients in 25 countries, according to AbbVie.
The drugmaker stated it would file for regulatory approval in the EU in early May 2014. FDA granted the regimen Breakthrough Therapy designation in May of last year.
