AbbVie Moves Forward on US, EU Accelerated Review of Hepatitis C Drug
AbbVie reports 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 (EMA).
Accelerated assessment, which is designated to new medicines of major public health interest, was granted by the EMA for AbbVie’s investigational HCV regimen in May 2014. Validation of the MAAs confirms that the submissions are complete and starts the EMA’s centralized review process. If approved, AbbVie’s regimen could be available for marketing in the European Union (EU) in the first quarter of 2015. The MAAs were submitted on May 8, 2014 and are supported by data from a large clinical program that six Phase III studies of more than 2,300 GT1 patients in over 25 countries. Review of the MAAs will be conducted under the centralized licensing procedure, which, when finalized, provides marketing authorizations in all 28 member states of the EU.
On June 13, 2014, AbbVie announced that the new drug application (NDA) for AbbVie’s regimen was accepted and granted priority review by the US Food and Drug Administration (FDA).
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.