R&D Insight Report


, Volume 74, Issue 2, pp 273-282

First online:

Sofosbuvir: First Global Approval

  • Gillian M. KeatingAffiliated withP.W.G. Writer, Adis
  • , Asha VaidyaAffiliated withAdis R & D Insight Email author 

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Sofosbuvir (Solvadi™), a nucleotide analogue hepatitis C virus NS5B polymerase inhibitor, is under development with Gilead Sciences for the once-daily, oral treatment of chronic hepatitis C. Oral sofosbuvir has been approved in the US for the treatment of chronic hepatitis C as a component of a combination antiviral regimen. In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of sofosbuvir for the treatment of chronic hepatitis C. This article summarizes the milestones in the development of sofosbuvir leading to this first approval for chronic hepatitis C.