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FDA Alerts
Gastroenterology
Infectious Diseases

FDA approves Vemlidy for chronic hepatitis B virus infection in pediatric patients

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The U.S. Food and Drug Administration approved the supplemental new drug application for Vemlidy (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients ≥12 years of age with compensated liver disease, according to a press release.

This approval was based on 24-week data from a Phase 2 clinical trial comparing treatment with Vemlidy 25 mg to placebo among 70 treatment-naïve and treatment-experienced patients between the ages of 12 and 18 years weighing at least 35 kg. The study met its primary endpoint of percentage of patients with HBV DNA levels below 20 IU/mL at 24 weeks of therapy; overall, 21% (10/47) of subjects treated with Vemlidy 25 mg achieved HBV DNA <20 IU/mL at 24 weeks compared to 0% (0/23) of subjects treated with placebo.

“Chronic hepatitis B can have a significant long-term health impact on children, including the development of liver cancer later in life if the disease is left untreated, which is compounded by treatment challenges in this population,” said Kathleen Schwarz, MD, Pediatric Gastroenterologist, Rady Children’s Hospital-San Diego, an investigator in the Vemlidy clinical trial. “As a clinician, I recognize the critical importance of treating this disease as quickly as possible to help avoid complications and potential damage to the liver. In the clinical trial, we saw that tenofovir alafenamide may represent an effective treatment option for people as young as 12 years of age living with this chronic disease.”

Read the full press release here.

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