ABT-450 plus ritonavir/ombitasvir regulatory update

AbbVie said FDA accepted and granted Priority Review to an NDA for the company's all-oral HCV regimen, which has breakthrough therapy designation from the agency. The NDA covers a regimen of ABT-450 plus Norvir ritonavir, ABT-267 and ABT-333 with and without ribavirin to treat HCV genotype 1 infection. AbbVie declined to disclose the PDUFA date; the company submitted the NDA in April. The regimen is also under accelerated assessment in the EU, with a decision expected early next year. An accelerated assessment shortens the review period to 150 days from 210 (see BioCentury, May 12).

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. ...