FDA approves Gilead's Vemlidy for HBV

Gilead Sciences Inc. (NASDAQ:GILD) said FDA approved its once-daily tablet Vemlidy tenofovir alafenamide (TAF; GS-7340) to treat chronic HBV infection in patients with compensated liver disease. Gilead spokesperson Kelsey Grossman told BioCentury that Vemlidy will be available next week at a price of $997.77 for a 30-tablet bottle, "at parity" with the price of Gilead's HBV therapy Viread tenofovir disoproxil fumarate (TDF).

Vemlidy's label has a boxed warning noting risks of lactic acidosis or severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of disease...