Gilead Sciences Inc. (GILD) announced that the Japanese Ministry of Health, Labour and Welfare has approved Sovaldi (sofosbuvir), a once-daily nucleotide analog polymerase inhibitor, for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus infection with or without compensated cirrhosis. Sovaldi is the first product to be marketed by Gilead in Japan.
Sovaldi's approval is supported by data from a Phase 3 clinical trial conducted in Japan among treatment-naïve and treatment-experienced genotype 2 patients. The approval is also supported by SVR12 results from four international Phase 3 studies (FISSION, FUSION, POSITRON and VALENCE), which included genotype 2 HCV patients.
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