09:27 AM EDT, 03/28/2024 (MT Newswires) -- Gilead Sciences ( GILD ) said Thursday that the US Food and Drug Administration has approved a supplemental new drug application for Vemlidy 25 mg tablets as a once-daily potential treatment for chronic hepatitis B in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease.

Vemlidy, also known as tenofovir alafenamide, was approved by the FDA in 2016 as a once-daily treatment for adults with chronic hepatitis B with compensated liver disease, and in 2022 for patients 12 years of age and older.

Vemlidy's approval followed data from a phase 2 clinical trial comparing treatment with Vemlidy to a placebo among 18 patients aged 6 to 12 years and weighing at least 25 kg.

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