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Epclusa Clinical Development Timeline

Executive Summary

Chronicle of the development and FDA review of Gilead’s fixed-dose combination of sofosbuvir and velpatasvir for hepatitis C.

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Gilead's Epclusa: FDA Sought To Push Efficacy Bar Higher In Hepatitis C

Drug Review Profile of the pan-genotypic HCV treatment shows agency staff debating whether fixed-dose combination's strong efficacy in certain genotype 3 patients could be further maximized by adding ribavirin.

Harvoni Approval Led To Narrowing Of Epclusa's Breakthrough Status

US FDA cited strong efficacy, good safety of Gilead's Harvoni and AbbVie's Viekira Pak in rescinding breakthrough therapy designation for the sofosbuvir/velpatasvir fixed-dose combination in hepatitis C patients with genotype 1 infection.

Epclusa Reviewers

FDA staff who participated in the review of Gilead’s pan-genotypic hepatitis C drug.





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