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Vemlidy Approval History

Reviewed on Nov 10, 2016 by J.Stewart BPharm
  • FDA approved: Yes (First approved November 10th, 2016)
  • Brand name: Vemlidy
  • Generic name: tenofovir alafenamide
  • Dosage form: Tablets
  • Company: Gilead Sciences, Inc.
  • Treatment for: Hepatitis B

Vemlidy (tenofovir alafenamide) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.

FDA approval of Vemlidy was supported by data from two Phase 3 studies among 1,298 treatment-naïve and treatment-experienced adult patients with chronic HBV infection who were randomly assigned and treated with either Vemlidy or Viread (tenofovir disoproxil fumarate). In both studies, Vemlidy proved to have efficacy similar to Viread, but with improved renal and bone laboratory safety parameters.

Vemlidy is an oral tablet taken once daily with food. Vemlidy carries a boxed warning to alert health care professionals and patients of the risks for lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B. Common side effects include headache, abdominal pain, fatigue, cough, nausea, and back pain.

Development History and FDA Approval Process for Vemlidy

Nov 10, 2016Approval FDA Approves Gilead’s Vemlidy (tenofovir alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection
Jan 12, 2016Gilead Submits New Drug Application to U.S. FDA for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B
Jan  5, 2016Gilead Announces Top-Line Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection

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