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European Commission grants marketing authorization for Gilead Sciences Inc's Sovaldi for the treatment of chronic hepatitis C infection

Friday, 17 Jan 2014 09:09am EST 

Gilead Sciences Inc:Says the European Commission has granted marketing authorization for Sovaldi (sofosbuvir) 400 mg tablets.Says Sovaldi is an once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection in adults, in combination with other antiviral agents (ribavirin (RBV) and pegylated interferon alpha (peg-IFN)).Says marketing authorization follows an accelerated assessment by the European Medicines Agency, a designation that is granted to new medicines of major public health interest, and allows for the marketing of Sovaldi in all 28 countries of the European Union.Says Sovaldi has been studied in hepatitis C virus (HCV) genotypes 1-6. The efficacy of Sovaldi has been established in patients with genotypes 1-4, in those awaiting liver transplantation and those with HCV/HIV-1 co-infection. 

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28 Nov 2014