FDA Advisers Urge Approval of Gilead’s ‘Historic’ Hep C Drug

The FDA’s Antiviral Drugs Advisory Committee on Friday voted to recommend approval of Gilead Sciences’ hepatitis C drug candidate sofosbuvir, with some panelists relishing the “historic moment.” Gilead is seeking an indication for sofosbuvir use in combination with other agents in adult patients with chronic hepatitis C with genotypes 1 to 6 and/or adult patients awaiting liver transplantation.
Drug Industry Daily