Gilead's Sovaldi gains EC approval for chronic hepatitis C

20 January 2014

US antivirals specialist Gilead Sciences (Nasdaq: GILD) revealed on Friday that it has received marketing authorization from the European Commission for Sovaldi(sofosbuvir), a 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]).

The approval 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.

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. The clinical data supporting the use of Sovaldi in patients with genotypes 5 and 6 is limited.

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