Gilead HCV drug sofosbuvir wins US priority review

The US FDA granted a priority review for Gilead Sciences' new drug application (NDA) for sofosbuvir, an oral nucleotide analogue inhibitor, as a once-daily treatment for chronic hepatitis C virus (HCV) infection, the leading cause of liver cancer and liver transplantation in the US – affecting up to 4 million Americans.

The US FDA granted a priority review for Gilead Sciences' new drug application (NDA) for sofosbuvir, an oral nucleotide analogue inhibitor, as a once-daily treatment for chronic hepatitis C virus (HCV) infection, the leading cause of liver cancer and liver transplantation in the US – affecting up to 4 million Americans.

The FDA set 8 December as the Prescription Drug User Fee Act action date for the sofosbuvir NDA, Gilead said...

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