Gilead scores expanded label for hepatitis B drug Vemlidy in children 6 years and older

The FDA ex­pand­ed the la­bel for Gilead’s he­pati­tis B drug Vem­lidy on Thurs­day to pa­tients as young as 6 years old.

Vem­lidy, or teno­fovir alafe­namide, is a once-dai­ly treat­ment for chron­ic he­pati­tis B that pulled in $862 mil­lion in sales for Gilead in 2023, up from $842 mil­lion in 2022.

The reg­u­la­tor orig­i­nal­ly ap­proved the ther­a­py in 2016 for adults with chron­ic he­pati­tis B in­fec­tions and com­pen­sat­ed liv­er dis­ease. Then in 2022, the la­bel was ex­pand­ed to in­clude pa­tients who are at least 12 years old with the in­fec­tion and com­pen­sat­ed liv­er dis­ease.

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