Daklinza is the first NS5A complex inhibitor cleared in the European Union (EU) and will be made available to be used with other therapies, providing a shorter treatment duration (12 or 24 weeks) versus 48-week treatment with interferon- and ribavirin-based regimens. Daklinza, when combined with sofosbuvir, is an all-oral, interferon-free regimen that resulted in cure rates of up to 100% in clinical studies, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors.
The authorisation permits the commercialisation of Daklinza in all 28 EU member states and follows an accelerated evaluation by the European Committee for Medicinal Products for Human Use (CHMP).
The licence of Daklinza is based on findings from numerous studies, including an open-label, randomised study of the drug plus sofosbuvir in genotypes 1, 2, and 3, including patients with no response to previous treatment with telaprevir or boceprevir and patients with fibrosis. Data demonstrated that Daklinza plus sofosbuvir resulted in SVR12 (sustained virologic response 12 weeks after the end of treatment; a functional cure) in 99% of treatment-naive patients with HCV genotype 1, 100% of patients with genotype 1 who had failed treatment with either telaprevir or boceprevir, 96% of those with genotype 2 and 89% of those with genotype 3.
The combination also resulted in low rates of discontinuation (
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