AbbVie submits NDA for all-oral HCV regimen

AbbVie Inc. (NYSE:ABBV) submitted an NDA to FDA for its all-oral regimen comprising ABT-450 plus the company's Norvir ritonavir, ABT-267 and ABT-333 with and without ribavirin to treat HCV genotype 1 infection. The regimen has breakthrough therapy designation from FDA. AbbVie plans to submit an MAA to EMA for the regimen in early May.

ABT-450, an HCV NS3/4A protease inhibitor, is the lead HCV protease inhibitor discovered by Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) and Abbott Laboratories (NYSE:ABT), which spun out its pharmaceutical business into AbbVie. ABT-267 is an HCV NS5A protein inhibitor, and ABT-333 is a non-nucleoside HCV NS5B polymerase inhibitor. ...