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Gilead’s Sovaldi Gains EU Approval

Authorization follows accelerated EMA assessment

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By: Kristin Brooks

Managing Editor, Contract Pharma

Gilead Sciences, Inc. was granted marketing authorization by the European Commission for Sovaldi (sofosbuvir) 400 mg tablets, 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. The marketing authorization follows an accelerated assessment by the EMA.
 
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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