Daklinza (daclatasvir; Bristol-Myers Squibb) is a first-generation NS5A inhibitor approved for use for the treatment of genotype 1/2/3/4 (GT-1/2/3/4) chronic hepatitis C virus patients. Within the US and five major EU markets (France, Germany, Italy, Spain, and the UK), Daklinza is also approved for use in combination with Sovaldi (sofosbuvir; Gilead) for the treatment of GT-1/3 patients. Additionally, Daklinza is approved in the EU for the treatment of GT-2/4 patients, either in combination with Sovaldi or with peginterferon alfa and ribavirin (GT-4 only). In Japan, Daklinza is approved in combination with Sunvepra (asunaprevir; Bristol-Myers Squibb), and in a fixed-dose combination with asunaprevir and beclabuvir (branded as Ximency) for the treatment of GT-1 patients only.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Daklinza : Hepatitis C
LIST OF FIGURES 10 Figure 1: Daklinza for hepatitis C – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Daklinza for hepatitis C
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of Daklinza for hepatitis C
14 Figure 4: Daklinza sales for hepatitis C across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES 5 Table 1: Daklinza drug profile
7 Table 2: Pivotal studies supporting approvals of Daklinza
15 Table 3: Daklinza sales for hepatitis C across the US, Japan, and five major EU markets, by country ($m), 2017–26
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