FDA Expands Approval of Gilead’s Hep B Drug Vemlidy
The FDA has approved Gilead Sciences’ supplemental New Drug Application (sNDA) for Vemlidy (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus infection in pediatric patients 12 years and older with compensated liver disease.
The drug, a nucleoside analog reverse transcriptase inhibitor, reduces the multiplication of the hepatitis B virus in the body.
Vemlidy was previously approved for adult patients with the same condition.
The expanded approval was based on 24-week data from a phase 2 study in which 21 percent of participants treated with Vemlidy demonstrated meaningful reductions in hepatitis B virus DNA levels.