The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Vemlidy® (tenofovir alafenamide) for the treatment of chronic hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older with compensated liver disease. Previously, the treatment was only approved for adults.
The approval was supported by data from a randomized, double-blind, placebo-controlled phase 2 trial (ClinicalTrials.gov Identifier: NCT02932150 [Trial 1092]), which evaluated the efficacy and safety of tenofovir alafenamide, an HBV nucleoside analog reverse transcriptase inhibitor, in 70 treatment-naïve and treatment-experienced patients aged 12 to less than 18 years weighing at least 35kg with chronic HBV infection. Patients were randomly assigned to receive either tenofovir alafenamide 25mg (n=47) or placebo (n=23) once daily.
Findings showed that the trial met the primary endpoint with 21% of patients treated with tenofovir alafenamide achieving HBV DNA less than 20 IU/mL at week 24 compared with 0% of patients in the placebo group. The safety profile of tenofovir alafenamide in pediatric patients was similar to that observed in adults. The most common adverse reaction associated with treatment is headache.
“While pediatric hepatitis B prevalence has dropped significantly in the US, children who develop chronic hepatitis B following an acute infection can experience lifelong health impact,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “With an established safety profile and once-daily dosing, Vemlidy provides provides physicians a new option to address the treatment needs of pediatric patients living with hepatitis B.”
Vemlidy is supplied as 25mg tablets in 30-count bottles.
- US Food and Drug Administration approves Vemlidy® (tenofovir alafenamide) for treatment of chronic hepatitis B virus infection in pediatric patients. News release. Gilead Sciences. Accessed November 2, 2022. https://www.businesswire.com/news/home/20221102005034/en/U.S.-Food-and-Drug-Administration-Approves-Vemlidy%C2%AE-tenofovir-alafenamide-for-Treatment-of-Chronic-Hepatitis-B-Virus-Infection-in-Pediatric-Patients
- Vemlidy. Package insert. Gilead Sciences; 2022. Accessed November 2, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208464s014lbl.pdf