FDA extends Vemlidy approval for chronic hepatitis B to children as young as 6 years

March 28, 2024

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The FDA has updated the label indication for Vemlidy 25 mg for the treatment of chronic hepatitis B virus with compensated liver disease, expanding the patient population to include children aged 6 years and older who weigh at least 25 kg.

Vemlidy (tenofovir alafenamide, Gilead Sciences) — a nucleoside analog reverse transcriptase inhibitor — was previously approved for the adult population in 2016 and expanded in 2022 to include children as young as 12 years.

The FDA extends Vemlidy approval for chronic hepatitis B to children as young as 6 years.

“Chronic hepatitis B can have a significant and lasting impact on the health of children,” Chaun-Hao Lin, MD, associate professor of clinical pediatrics at Krek School of Medicine of USC, said in a Gilead press release. “If left untreated, hepatitis B can lead to liver cirrhosis and liver cancer. As a clinician, I am well aware of the critical importance of promptly treating this disease to avoid possible complications and liver damage. The clinical trial demonstrated that tenofovir alafenamide may represent an effective treatment option for children as young as 6 years old affected by this chronic disease.”

The agency based its decision on week 96 data from an ongoing phase 2 clinical trial, which compared once-daily Vemlidy 25 mg with placebo among 18 treatment-naïve and treatment-experienced patients aged 6 to 12 years who weighed at least 25 kg.

Results showed that patients who were treated with Vemlidy as well as those who were initially treated with placebo and later switched to open-label Vemlidy after week 24 both showed “progressive increases” in virological suppression through week 96 overall and within both children and adolescent study cohorts.

“The expanded indication for Vemlidy for the treatment of children as young as 6 years old is a testament to the safety, tolerability and efficacy profile of this therapy,” Frank Duff, MD, senior vice president and virology therapeutic area head at Gilead Sciences, said in the release. “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 pediatric 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.”

Vemlidy includes a boxed warning in its product label regarding the risks for lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of HBV, according to Gilead.

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