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FDA Approves Gilead’s Vemlidy (tenofovir alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection

Posted 15 Nov 2016 by Drugs.com

FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 10, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Vemlidy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B. See below for important safety information. Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 300mg. Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it ca ... Read more

Related support groups: Hepatitis B, Viread, Tenofovir, Vemlidy, Tenofovir Alafenamide

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Vemlidy Patient Information at Drugs.com