BioCentury
ARTICLE | Clinical News

ABT-450 plus ritonavir/ombitasvir regulatory update

April 28, 2014 7:00 AM UTC

AbbVie 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. ...