Japanese approval for hepatitis drug Vemlidy

19 December 2016

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Vemlidy(tenofovir alafenamide) 25mg, a once-daily treatment for suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function.

Vemlidy, from US biotech giant Gilead Sciences (Nasdaq: GILD), is a novel targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of tenofovir disoproxil fumarate (TDF) 300mg. Data show that Vemlidy has greater plasma stability and delivers tenofovir to hepatocytes more efficiently compared to TDF. As a result, Vemlidy can be given at a lower dose, reducing the concentration of tenofovir in the bloodstream. Vemlidy has also shown improvements in renal and bone laboratory safety parameters compared to TDF.

GSK will market Vemlidy in Japan

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