Priority Review for Gilead's sofosbuvir

FDA accepted and granted Priority Review to an NDA from Gilead Sciences Inc. (NASDAQ:GILD) for sofosbuvir ( GS-7977) to treat chronic HCV infection. The PDUFA date is Dec. 8. The company said the application covers the use of sofosbuvir in combination with ribavirin as an all-oral therapy to treat HCV genotypes 2 and 3 infection; and sofosbuvir in combination with ribavirin and pegylated interferon to treat HCV genotypes 1, 4, 5 and 6 infection in treatment-naïve patients. The product is also under accelerated assessment in the EU for the same indications. An accelerated assessment shortens the review period to 150 days from 210. Sofosbuvir is a single isomer form of a nucleotide analog HCV NS5B polymerase inhibitor. ...