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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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