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.

“As a clinician, I am well aware of the critical importance of promptly treating this disease to avoid possible complications and liver damage,” Chuan-Hao Lin, an associate professor of clinical pediatrics at USC’s Keck School of Medicine, said in Gilead’s statement.

The study that led to Vemlidy’s expanded approval is called Trial 1092….
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