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Danoprevir: First Global Approval

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Abstract

Ascletis has developed danoprevir (Ganovo®), an orally-administered hepatitis C virus NS3 protease inhibitor, as a treatment for hepatitis C. Based on positive results in phase II and phase III trials in patients with hepatitis C, danoprevir, in combination with ritonavir, peginterferon alfa and ribavirin was recently approved for marketing in China for the treatment of treatment-naive patients with non-cirrhotic genotype 1b chronic hepatitis C. This article summarizes the milestones in the development of danoprevir leading to this first approval.

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Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Anthony Markham & Susan J. Keam

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  1. Anthony Markham
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  2. Susan J. Keam
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Corresponding author

Correspondence to Susan J. Keam.

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Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham, a contracted employee of Adis/Springer, and S.J. Keam, a salaried employee of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

Additional information

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Markham, A., Keam, S.J. Danoprevir: First Global Approval. Drugs 78, 1271–1276 (2018). https://doi.org/10.1007/s40265-018-0960-0

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