How Sovaldi Won A Broad Label: Emerging Data Swayed Reluctant FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Agency reviewers were skeptical about awarding Gilead’s sofosbuvir an indication for use in combination with other, unspecified agents for treating chronic hepatitis C – a game-changing approach for the fast-evolving field. However, data submitted late in the review process from two ongoing Phase III studies convinced FDA that a broad indication was justified.
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What’s In A Name? Janssen’s Loss Of Sovriad Was Gilead’s Gain With Sovaldi
FDA initially rejected both sponsors’ preferred proprietary names for their hepatitis C treatments due to the risk of confusion with each other. Janssen had to settle for Olysio, its backup name for simeprevir, leaving Gilead to claim title to its preferred name for sofosbuvir.