This sNDA extends the indication of Vemlidy, a once a day 25mg tablet for usage in children aged six years and above weighing a minimum of 25kg with compensated liver disease.
Vemlidy, a targeted prodrug of tenofovir, was initially approved by the US regulator in 2016 for adults with chronic HBV infection and compensated liver disease.
The recent approval builds on a 2022 decision which allowed its use in paediatric patients aged 12 years and above.
The American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) recommend use of Vemlidy as a preferred or first-line treatment for adults with chronic HBV infection.
The approval for the expanded indication is backed by findings from a Phase II clinical trial known as Trial 1092.
It evaluated Vemlidy in patients aged six to less than 12 years over a 96-week period versus placebo.
The study included 18 treatment-naïve and treatment-experienced children who showed progressive increases in virological suppression rates up to Week 96.
The trial results demonstrated that subjects in both the Vemlidy group and the placebo group who switched to open-label Vemlidy after 24 weeks, experienced significant improvements.
Gilead Sciences Virology Therapeutic Area head and senior vice-president Frank Duff said: “The expanded indication for Vemlidy for the treatment of children as young as six years old is a testament to the safety, tolerability and efficacy profile of this therapy.
“Effective and tolerable options for children require our best science and a dedicated focus. The work of our Gilead Pediatric Center of Excellence is responsible for coordinating paediatric clinical trials for treatments for cancer, HIV, hepatitis B, and Covid-19 and we will continue our research to help address unmet treatment needs for children.”