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.
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