Gilead Sciences, Inc. (GILD)
Primarily due to hepatitis C virus (HCV), Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people in Japan chronically infected with HCV, 70% - 80% are infected with the genotype 1 strain of the virus.
GILD said on Friday that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the company's Harvoni(R) (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults.
GILD's Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved by the MHLW under the trade name Sovaldi(R) in March 2015. Harvoni is indicated for the suppression of viremia in patients with genotype 1 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis, with a treatment duration of 12 weeks.
According to GILD, its Harvoni was safe and well-tolerated, and achieved cure rates of up to 100% in Japanese Phase 3 studies.
Gilead Sciences (GILD) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.
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