Japan's MHLW approves hepatitis C drug Epclusa

9 January 2019

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg), a once-daily treatment for adults with chronic hepatitis C virus (HCV) infection with decompensated cirrhosis, and for patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have had prior treatment with a direct-acting antiviral therapy (DAA).

Gilead Sciences’ (Nasdaq: GILD) Epclusa received marketing approval from the US Food and Drug Administration and the European Commission in 2016 as the first pan-genotypic STR for HCV infection. It is also approved for use in 54 countries. Epclusa generated global sales of $477 million in the third quarter of 2018, down 46% on the like 2017 period.

A new option for difficult-to-treat patient populations

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