CHMP backs Bristol-Myers' daclatasvir

EMA's CHMP backed the use of HCV candidate Daklinza daclatasvir ( BMS-790052) from Bristol-Myers Squibb Co. (NYSE:BMY), which also disclosed on Friday that FDA accepted for Priority Review an NDA for the selective HCV NS5A protein inhibitor. CHMP backed Daklinza in combination with other agents to treat HCV infection in adults with compensated liver disease, but BMS said it does not know the specific combinations and indications. The company is seeking approval of Daklinza in combination with HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) and other undisclosed agents as part of an all-oral, ribavirin-free regimen for treatment-naïve patients with HCV genotypes 1, 2 and 3 infections and patients who have failed protease inhibitor treatment. The pharma is also seeking approval of Daklinza in combination with ribavirin and peginterferon for patients with HCV genotype 4 infection, including those with cirrhosis. Daklinza is under accelerated assessment in the EU. ...