FDA panel backs Gilead's sofosbuvir
FDA's Antiviral Drugs Advisory Committee voted 15-0 in favor of approval of sofosbuvir ( GS-7977) from Gilead Sciences Inc. (NASDAQ:GILD) in combination with ribavirin to treat HCV genotypes 2 and 3 infection in both treatment-naïve and treatment-experienced patients -- moving the compound a step closer to becoming the first all-oral, interferon-free regimen to be approved in the world. The committee also voted unanimously in favor of approval for sofosbuvir in combination with ribavirin and pegylated interferon to treat HCV genotypes 1 and 4 infection in treatment-naïve patients only. On a separate discussion question, a majority of panel members said that despite an absence of data for sofosbuvir in treatment-experienced genotype 1 and 4 patients they felt comfortable approving the compound for the subgroup. Sofosbuvir is under Priority Review, with a Dec. 8 PDUFA date. The compound is a single isomer form of a nucleotide analog HCV NS5B polymerase inhibitor.
On Thursday, the advisory committee backed approval of simeprevir from Johnson & Johnson (NYSE:JNJ) and Medivir AB (SSE:MVIR B) to treat HCV genotype 1 infection in combination with interferon and ribavirin (see BioCentury Extra, Oct. 24). ...