Vemlidy approved for chronic HBV infection with compensated liver disease
by John Gever
Managing Editor, MedPage TodayNovember 10, 2016
The FDA has approved tenofovir alafenamide (TAF), to be sold as Vemlidy, for adults with chronic hepatitis B infection with compensated liver disease, said manufacturer Gilead Sciences on Thursday.
TAF is a prodrug for tenofovir, an antiviral agent previously approved under the name Viread for HIV and HBV infection.
The new version will come with a boxed warning about risk of lactic acidosis and severe hepatomegaly with steatosis, as well as post-treatment severe acute exacerbation of hepatitis B.
Two phase III trials reported earlier this year supported the approval. Those studies found the drug was as effective as Viread but with less toxicity. Gilead said additional data on TAF would be presented at the American Association for the Study of Liver Diseases meeting that begins Friday.
The company did not indicate what it would charge for the new drug, but promised that its patient assistance programs would help eligible patients with out-of-pocket costs.