ABT-450 plus ritonavir/ombitasvir regulatory update

AbbVie and Enanta said EMA accepted for review a pair of MAAs for AbbVie’s 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 applications were submitted on May 8 and are under accelerated assessment, which shortens the review period to 150 days from 210 (see BioCentury, May 12). One MAA covers a tablet comprising ABT-267, ABT-450 and ritonavir; the other covers ABT-333. The partners said that the regimen could be launched in the EU in 1Q15.

Earlier this month, FDA accepted and granted Priority Review to an NDA for the regimen. AbbVie declined to disclose the PDUFA date; the company submitted the NDA in April (see BioCentury, June 16). ABT-267 is an HCV NS5A protein inhibitor, and ABT-333 is a non-nucleoside HCV NS5B polymerase inhibitor. AbbVie markets Norvir, an HIV protease inhibitor. ...