Gilead Sciences, Inc. (GILD) Submits New Drug Application To Japan’s Pharmaceutical And Medical Devices Agency For Sofosbuvir For Chronic Hepatitis C
6/27/2014 9:41:21 AM
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of sofosbuvir, a once-daily nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The data in the NDA support the use of sofosbuvir with ribavirin (RBV) for 12 weeks in patients with genotype 2 HCV infection. If approved, sofosbuvir would form the basis of the first all-oral, interferon-free treatment regimen for genotype 2 patients in Japan.
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