FDA approves Gilead’s hepatitis B treatment Vemlidy

SILVER SPRINGS, Md. — The Food and Drug Administration has approved Vemlidy (tenofovir alafenamide, TAF, 25 mg), a new once-daily treatment for hepatitis B infection with compensated liver disease from Gilead Sciences. Vemlidy comes with a boxed warning about the risk of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B. 

 

“Since the mid-1990s, Gilead has been working to improve and simplify care for people living with chronic hepatitis B,” Gilead Sciences president and CEO John Milligan said. “Vemlidy is the first medication approved to treat this disease in nearly a decade, and we are excited to offer a new, effective option to help advance long-term care for patients.”

 

Vemlidy is a targeted prodrug of tenofovir that has shown antiviral efficacy similar to and a dose that’s less than one-tenth of that in Gilead’s Viread (tenofovir disoproxil fumarate, TDF, 300 mg). Due to greater plasma stability in Vemlidy, it can more efficiently deliver tenofovir and can be given at a lower dose, which leads to less of its in the bloodstream.