ABT 450/r, ABT 267, ABT 333 combination submitted to FDA for Hepatitis C - AbbVie

AbbVie has submitted a New Drug Application (NDA) to the FDA seeking approval for ABT-450/r and ABT-267 and ABT-333, an all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) Hepatitis C virus (HCV) infection. The NDA is supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date,1 with six Phase III studies that included more than 2,300 patients in over 25 countries.

The regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg with or without RBV (weight-based), dosed twice daily. AbbVie plans to submit applications for regulatory approval of its regimen in the European Union in early May.