Sovaldi Clinical Development
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A timeline chronicling the development of Gilead’s hepatitis C treatment sofosbuvir.
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Sovaldi Reviewers
FDA staff that participated in the review of Gilead’s sofosbuvir for chronic hepatitis C.
Better Late Than Never: “Breakthrough” Status Aided Sovaldi’s On-Time Approval
Although Gilead’s hepatitis C drug picked up the “breakthrough therapy” moniker with just two months left in the NDA review cycle, the designation enabled FDA staff to analyze new VALENCE and PHOTON-1 trial data and still approve sofosbuvir by the PDUFA goal date.
How Sovaldi Won A Broad Label: Emerging Data Swayed Reluctant FDA
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.