FDA approves new indication for Vemlidy
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy (tenofovir alafenamide) 25mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older with compensated liver disease.
Developed and marketed by us biotech major Gilead Sciences (Nasdaq: GILD), Vemlidy has previously gained FDA for the treatment of adults with this chronic liver disease.
Vemlidy is recommended as a preferred or first-line treatment for adults with chronic HBV with compensated liver disease in guidelines from the American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL). Vemlidy has a boxed warning in its product label regarding post-treatment severe acute exacerbation of hepatitis B.
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