Gilead’s Vemlidy secures expanded pediatric approval for chronic hepatitis B in Korea

The Ministry of Food and Drug Safety has approved an expanded indication for Vemlidy (ingredient: tenofovir alafenamide), allowing its use in chronic hepatitis B (CHB) treatment for children aged six and older weighing at least 25 kilograms.

The approval marks a significant milestone for pediatric hepatitis B care in Korea, as Vemlidy becomes the only tenofovir-based therapy authorized for use in children as young as six.

Previously, CHB treatment options were limited to entecavir for patients aged two and older, and tenofovir disoproxil fumarate (TDF)-based therapies, such as Viread, which are indicated for patients aged 12 and above. Until now, Vemlidy had only been approved for adult patients.

Originally developed to improve kidney and bone safety over previous tenofovir regimens, Vemlidy has demonstrated long-term efficacy and tolerability through extensive clinical trials spanning over eight years.

With this expanded indication, Gilead expects that younger pediatric patients will now have access to a modern antiviral with a well-established safety and efficacy profile, addressing an important gap in long-term hepatitis B care.

The expanded indication is based on a global phase 3 clinical trial that enrolled 88 patients aged six to under 18 years with chronic hepatitis B. The randomized, double-blind, placebo-controlled trial transitioned into an open-label extension through 96 weeks and evaluated virologic suppression, safety, and tolerability.

At week 96, 61 percent of patients in the Vemlidy group achieved HBV DNA levels below 20 IU/mL, compared to 48 percent in the group that switched from placebo to Vemlidy. Notably, no treatment-emergent resistance to TAF was observed, and safety outcomes in pediatric patients mirrored those seen in adults. No serious adverse events related to TAF were reported, and changes in renal function and bone mineral density remained comparable to placebo over the 96-week period.

“The expanded pediatric indication for Vemlidy offers a meaningful advance for children living with chronic hepatitis B, enabling earlier intervention with a treatment that offers improved safety and convenience,” said Kwon Sun-hee, Senior Director of Gilead Sciences Korea’s Virology Business Unit. “For over three decades, Gilead has led innovation in antiviral care. With this expansion, we aim to ensure that all patients, regardless of age, have access to optimal hepatitis B therapy.”

Under current regulatory provisions, the newly approved pediatric indication is exclusive to Vemlidy and will not be extended to generic products for four years following the approval date. The recommended dosage remains one tablet once daily, with or without food, the same as the adult regimen.