FDA Approves Gilead’s new Hepatitis B Therapy

FDA has approved a Gilead Sciences NDA for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus infection with compensated liver disease. “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,” the company says. “Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, Vemlidy improved renal and bone laboratory safety parameters compared to Viread.” The approval required that Vemlidy bear a boxed warning in its labeling about the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B, Gilead says.