ARTICLE | Clinical News

Asunaprevir regulatory update

March 3, 2014 8:00 AM UTC

Bristol-Myers Squibb said FDA granted breakthrough therapy designation for daclatasvir (BMS-790052) in combination with the pharma's asunaprevir to treat HCV genotype 1b infection. The pharma said the designation is based on data from an ongoing Phase III trial of an all-oral, ribavirin-free regimen of daclatasvir and asunaprevir. In January, EMA accepted for review and granted accelerated assessment to an MAA for daclatasvir to treat HCV infection in patients with compensated liver disease, including HCV genotypes 1, 2, 3 and 4 infection (see BioCentury, Jan. 13). The pharma said it plans to submit a regulatory application for daclatasvir in the U.S. this half. ...