EMA validates Marketing Authorization Applications for AbbVie’s hepatitis C treatment
US drugmaker AbbVie (NYSE: ABBV) announced today that the Marketing Authorization Applications (MAAs) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection have been validated and are under accelerated assessment by the European Medicines Agency.
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin (RBV). The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations.
Backed by Phase III studies
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