FDA to discuss Gilead's sofosbuvir

FDA's Antiviral Drugs Advisory Committee will meet on Oct. 25 to discuss an NDA from Gilead Sciences Inc. (NASDAQ:GILD) for sofosbuvir ( GS-7977) to treat chronic HCV infection. The product is under Priority Review, with a Dec. 8 PDUFA date. 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 single isomer form of a nucleotide analog HCV NS5B polymerase inhibitor is also under accelerated assessment in the EU for the same indications. An accelerated assessment shortens the review period to 150 days from 210. ...