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Sofosbuvir: First Global Approval

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Abstract

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.

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Authors and Affiliations

  1. Adis R & D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Asha Vaidya

  2. P.W.G. Writer, Adis, Auckland, New Zealand

    Gillian M. Keating

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  1. Gillian M. Keating
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  2. Asha Vaidya
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Correspondence to Asha Vaidya.

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This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

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Keating, G.M., Vaidya, A. Sofosbuvir: First Global Approval. Drugs 74, 273–282 (2014). https://doi.org/10.1007/s40265-014-0179-7

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