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

On Thursday, Gilead Sciences, Inc. (GILD) shared news of the FDA approving their supplemental new drug application (sNDA) which permits the expansion of the usage for Vemlidy, also referred to as its chemical name, tenofovir alafenamide 25 mg tablets.

The approval grants the authorization for Vemlidy to be employed as a once-daily treatment for chronic hepatitis B virus (HBV) infection. This is specifically for pediatric patients aged six years and older, who weigh at least 25 kg and have compensated liver disease.

Vemlidy previously gained FDA approval in 2022, permitting its use for pediatric patients aged 12 and older with compensated liver disease. Moreover, in 2016 it also achieved approval as a once-daily treatment for chronic HBV infection in adults.

The authorization for using Vemlidy in this specific pediatric patient group was supported by the Week 96 data derived from a Phase 2 clinical trial. The trial revealed the comparison between the treatment with Vemlidy 25 mg and the placebo.