FDA Approves New Drug for Chronic HBV Infection
The Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide [TAF]; Gilead) for the treatment of adults with hepatitis B virus (HBV) infection with compensated liver disease.
The approval of Vemlidy is supported by 48-week data from two international Phase 3 studies among 1,298 treatment-naïve and treatment-experienced adult patients with chronic HBV infection. Both studies met their primary endpoint of non-inferiority to Viread based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy.
Vemlidy is a nucleoside analog reverse transcriptase inhibitor and a targeted prodrug of tenofovir. In clinical trials, compared to Viread (tenofovir disoproxil fumarate [TDF]), Vemlidy improved renal and bone laboratory safety parameters as it is given at a lower dose (25mg vs 300mg), resulting in less tenofovir in the bloodstream, while at the same time providing similar antiviral efficacy.
The prescribing information for Vemlidy includes a boxed warning regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B.
Vemlidy will be available as a 25mg tablet in a 30-count bottle.
For more information visit Gilead.com.