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EMA validates Gilead's application for hepatitis C treatment sofosbuvir
22 May 2013 - 22 May 2013 - US Gilead Sciences (NASDAQ:GILD) said on Tuesday that its marketing application for its chronic hepatitis C virus (HCV) infection treatment sofosbuvir has been validated by the European Medicines Agency (EMA).

The data in the application, which was filed with the EMA in April, support the use of sofosbuvir, the company's once-daily oral nucleotide analogue inhibitor, 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-naive patients with genotype 1, 4, 5 and 6 HCV infection.

The company added that the EMA has accepted its request for accelerated assessment for sofosbuvir.
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