Gilead gets FDA nod – and boxed warning – for new hepatitis B drug

11 November 2016

Biotech giant Gilead Sciences (Nasdaq: GILD) has received approval from the US Food and Drug Administration (FDA) for its new treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.

Vemlidy (tenofovir alafenamide, TAF) will carry a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of HBV.

"Vemlidy is the first medication approved to treat this disease in nearly a decade"

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