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Enanta notes AbbVie granted FDA priority review for Hep C combo regimen

Enanta Pharmaceuticals (ENTA) announced that the New Drug Application for AbbVie’s (ABBV) investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection has been accepted by the FDA and has been granted priority review. The three direct-acting antiviral investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir co-formulated with ombitasvir 25mg, dosed once daily, and dasabuvir 250mg with or without ribavirin, dosed twice daily. ABT-450 is Enanta’s lead protease inhibitor developed through Enanta’s collaboration with AbbVie. Enanta confirmed that in the quarter ending June 30 it has now received from AbbVie milestone payments totaling $40M related to regulatory filings.