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How Sovaldi Won A Broad Label: Emerging Data Swayed Reluctant FDA

 
• By Sue Sutter

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.

Gilead Sciences Inc.’s submission late in the Sovaldi (sofosbuvir) review process of interim data from two Phase III trials overcame FDA reviewers’ initial skepticism about the appropriate breadth of the hepatitis C treatment’s indication, giving the sponsor the broad claim it sought for use in combination with other (unspecified) HCV treatments.

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