Gilead Sciences, Inc. (GILD) said Friday that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration has voted unanimously that the available data support approval of the once-daily nucleotide analogue sofosbuvir in combination with ribavirin for the treatment of chronic hepatitis C in adult patients with genotype 2 and 3 infection.
Committee members also voted unanimously that the available data support approval of sofosbuvir in combination with pegylated interferon and ribavirin for the treatment of chronic hepatitis C in treatment-naïve adult patients with genotype 1 and 4 infection.
The recommendations of the Advisory Committee are not binding, but will be considered by FDA as the agency completes its review of Gilead's New Drug Application for sofosbuvir.
Gilead submitted the NDA on April 8, and was granted a priority review. The FDA also granted sofosbuvir a Breakthrough Therapy designation. A target review date of December 8 has been set under the Prescription Drug User Fee Act.
The sofosbuvir NDA is supported mainly by data from four Phase 3 studies in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response 12 weeks after completing therapy.
Applications for marketing approval of sofosbuvir are also pending in the European Union, Australia, Canada, New Zealand, Switzerland and Turkey.
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