ABT-450 plus ritonavir/ombitasvir regulatory update

AbbVie 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. ...