Gilead Sciences, Inc. (GILD) said Friday that the U.S. 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 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 FDA has set a target review date under the Prescription Drug User Fee Act of December 8.
The data submitted in the NDA support the use of sofosbuvir and ribavirin as an all-oral therapy for patients with genotype 2 and 3 hepatitis C virus infection, and for sofosbuvir in combination with ribavirin and pegylated interferon for treatment-naïve patients with genotype 1, 4, 5 and 6 hepatitis C virus infection.
Sofosbuvir is an investigational product and its safety and efficacy have not yet been established.
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