AbbVie seeks FDA OK for triple direct-acting HCV antiviral
This article was originally published in Scrip
Executive Summary
AbbVie revealed on 22 April it had submitted a new drug application (NDA) to the FDA for the company's triple direct-acting antiviral (DAA) combination regimen – ABT-450/r, a protease inhibitor and ritonavir; ombitasvir (ABT-267), a NS5A inhibitor; and dasabuvir (ABT-333), a non-nucleoside polymerase inhibitor – with or without ribavirin for patients with hepatitis C virus (HCV) genotype 1.