Unanimous yes vote from FDA advisory panel for Gilead’s sofosbuvir in hep C

Following swiftly on a similar decision for Janssen’s hepatitis C drug simeprevir (The Pharma Letter October 25), the US Food and Drug Administration’s Antiviral Drugs Advisory Committee on Friday (October 25) gave its unanimous backing for biotech firm Gilead Sciences (Nasdaq: GILD) sofosbuvir.

The panel of outside experts voted 15-0 that the available data support approval of the once-daily nucleotide analogue sofosbuvir in combination with ribavirin for the treatment of chronic hepatitis C in adult patients with genotype 2 and 3 infection. Committee members also voted unanimously (15-0) that the available data support approval of sofosbuvir in combination with pegylated interferon and ribavirin for the treatment of chronic hepatitis C in treatment-naive adult patients with genotype 1 and 4 infection.

Panelists called the vote "historic" and a "game-changer," paving the way for a treatment that is more effective than current therapies and takes less time.