Epclusa ([sofosbuvir + velpatasvir]; Gilead) is a once-daily, fixed-dose combination of Gilead’s nucleotide NS5B polymerase inhibitor, sofosbuvir; and the company’s second-generation NS5A inhibitor, velpatasvir. The combination gained US and EU approval for the treatment of all six genotypes of hepatitis C in the US in June 2016 and in the EU in July 2016. Epclusa is also currently in Phase III development in Japan.
4 PRODUCT PROFILES
4 Epclusa : Hepatitis C
LIST OF FIGURES 10 Figure 1: Epclusa for hepatitis C – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Epclusa for hepatitis C
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of Epclusa for hepatitis C
15 Figure 4: Epclusa sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES 5 Table 1: Epclusa drug profile
6 Table 2: Pivotal studies supporting approvals of Epclusa
9 Table 3: Epclusa late-phase trial data in hepatitis C
16 Table 4: Epclusa sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017–26
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