Gilead Sciences announced on November 2 local time that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for its medication Vemlidy (tenofovir alafenamide) tablets for the treatment of chronic hepatitis B in pediatric patients aged 12 years and older, with a once-daily dosage.
Vemlidy was approved by the FDA in 2016 for once-daily treatment of adult patients with chronic hepatitis B and liver disease affecting liver function. In the guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL), this drug is recommended as a first-line therapy for such conditions to prevent the progression of the disease into liver cancer and others.