Gilead gains FDA priority review for hep C candidate sofosbuvir; new data on Boehringer's faldaprevir

10 June 2013

US biotech firm Gilead Sciences (Nasdaq: GILD) revealed on Friday (June 7) that the US Food and Drug Administration has granted priority review to the company's New Drug Application for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.

The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options. Gilead filed the NDA for sofosbuvir on April 8, and the FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of December 8, 2013. The Marketing Authorization Application for the drug was recently accepted for review by the European Medicines Agency (The Pharma Letter May 22).

The data submitted in this NDA support 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-naive patients with genotype 1, 4, 5 and 6 HCV infection.

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