BioCentury
ARTICLE | Company News

AbbVie's all-oral HCV regimen under review in EU

May 9, 2014 12:03 AM UTC

AbbVie Inc. (NYSE:ABBV) submitted a pair of MAAs to EMA for its all-oral HCV 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 company said EMA granted accelerated assessment for the regimen, which shortens the review period to 150 days from 210. One MAA covers a tablet comprising ABT-267, ABT-450 and ritonavir; the other covers ABT-333. AbbVie submitted an NDA to FDA for the regimen last month (see BioCentury Extra, April 22).

The submissions trigger a $20 million milestone payment from AbbVie to Enanta Pharmaceuticals Inc. (NASDAQ:ENTA). Enanta and Abbott Laboratories (NYSE:ABT) jointly discovered ABT-450, an HCV NS3/4A protease inhibitor. Abbott 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. ...