Posted from: Sunday, December 11, 2016 - 04:08 PM - Present

Vemlidy Approved for Hepatitis B

November 10, 2016 – The US FDA approved Vemlidy® (tenofovir alafenamide) manufactured by Gilead Sciences, Inc. Vemlidy is indicated to treat patients who have chronic hepatitis B and compensated (not yet progressed to cirrhosis) liver disease. Vemlidy maintains relatively constant blood levels, therefore it is effective at a lower dose (25mg/day) than Gilead’s previous hepatitis B drug, Viread® (tenofovir disoproxil fumarate), which is dosed at 300mg/day. As a result, Vemlidy does not cause as many side effects, particularly on bones and in kidneys, as Viread does. Labeling for Vemlidy does include a boxed warning that taking it may be associated with two potentially serious conditions -- lactic acidosis (excessive lactate accumulation) and hepatomegaly with steatosis (enlargement of the liver with fat deposits). In addition, hepatitis B may reactivate after treatment with Vemlidy ends. Recommended dosing is one tablet daily along with a meal or snack. Vemlidy will be launched through open distribution on Nov. 11, 2016, with a wholesale price of approximately $1,000 for a 30-day supply, which is comparable to Viread.


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Last Updated Thursday, September 19, 2019 - 05:17 PM.