FDA Agrees to Priority Review Oral Sofosbuvir for Chronic Hepatitis C

Gilead Sciences announced that FDA has granted priority review to its New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.

The NDA submission included data which supports the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.  The FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of December 8, 2013.

For more information call (800) GILEAD-5 or visit www.gilead.com.