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European Medicines Agency Validates Gilead Sciences, Inc. (GILD)'s Marketing Application for Sofosbuvir for the Treatment of Hepatitis C


5/22/2013 11:16:30 AM

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FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorisation Application (MAA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection, which was submitted to the European Medicines Agency (EMA) on April 17, 2013, has been fully validated and is now under assessment. The data submitted in this MAA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

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