EMA reviewing Bristol-Myers' daclatasvir

Bristol-Myers Squibb Co. (NYSE:BMY) said EMA accepted for review and granted accelerated assessment to an MAA for daclatasvir ( BMS-790052) to treat HCV infection in patients with compensated liver disease, including HCV genotypes 1, 2, 3 and 4 infection. BMS is seeking approval of the selective HCV NS5A protein inhibitor as part of an all-oral, ribavirin-free regimen in combination with sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) and other undisclosed agents for treatment-naïve patients with HCV genotypes 1, 2 and 3 infections and patients who have failed protease inhibitor treatment. BMS is also seeking approval of daclatasvir in combination with ribavirin and peginterferon for patients with HCV genotype 4 infection, including those with cirrhosis. The pharma said it plans to submit a regulatory application for daclatasvir in the U.S. this half.

In November, BMS submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for an interferon- and ribavirin-free oral regimen of daclatasvir and asunaprevir ( BMS-650032) to treat chronic HCV genotype 1b infection. Asunaprevir is an HCV NS3 protease inhibitor. ...