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.
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A year in our long-running series of deep dives into FDA review documents.
US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews
The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.
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.