Gilead Sciences, Inc. Submits New Drug Application To Japan’s Pharmaceutical And Medical Devices Agency For Sofosbuvir For Chronic Hepatitis C

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.

Help employers find you! Check out all the jobs and post your resume.