Gilead's SNDA For Vemlidy Gets FDA Approval To Treat Chronic HBV Infection In Pediatric Patients

(RTTNews) - Thursday, Gilead Sciences, Inc. (GILD) announced that the FDA has approved the supplemental new drug application or sNDA to expand the indication for Vemlidy also known as tenofovir alafenamide 25 mg tablets.

This approval allows for the once-daily treatment of chronic hepatitis B virus or HBV infection in pediatric patients aged six years and older, weighing at least 25 kg, with compensated liver disease.

In 2022, Vemlidy received FDA approval for pediatric patients aged 12 and older with compensated liver disease. Previously, in 2016, it was approved as a once-daily treatment for chronic HBV infection in adults.

The approval of Vemlidy for this pediatric patient population is backed by Week 96 data from a Phase 2 clinical trial that compared treatment with Vemlidy 25 mg to placebo.