The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy (tenofivir alafenamide) 25 mg tablets by Gilead Sciences, Inc., to treat chronic hepatitis B virus (HBV) in pediatric patients older than 12 years with compensated liver disease.
Vemlidy is a targeted, novel prodrug of tenofovir, which was previously approved by the US FDA in 2016 as a treatment for adults with chromic HBV infection and compensated liver disease. Vemlidy is recommended as a preferred treatment for chronic HBV patients in the guidelines from the European Association for the Study of the Liver (EASL).
The approval is supported by 24-week data from a Phase 2 clinical trial comparing Vemlidy 25 mg treatment to a placebo among 70 patients aged 12 years to less than 18 years. Vemlidy also has a boxed warning in its product label regarding the serious acute exacerbation of hepatitis B post treatment.
Gilead is focused on meeting the challenges in liver disease and impacting the course of the diseases. With once-daily dosing and established safety profile, Vemlidy provides physicians a new option to address the treatment needs of patients with hepatitis B, said Merdad Parsey, chief medical officer, Gilead Sciences, Inc.
