US FDA Approves Gilead Sciences Inc.’s Vemlidy to Treat Chronic Hepatitis B in Pediatric Patients


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.

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