FOSTER CITY (dpa-AFX) - Thursday, Gilead Sciences, Inc. (GILD) announced
that the FDA has approved the supplemental new drug application or sNDA to
expand the indication for Vemlidy also known as tenofovir alafenamide 25 mg
tablets.

This approval allows for the once-daily treatment of chronic hepatitis B virus
or HBV infection in pediatric patients aged six years and older, weighing at
least 25 kg, with compensated liver disease.

In 2022, Vemlidy received FDA approval for pediatric patients aged 12 and older
with compensated liver disease. Previously, in 2016, it was approved as a
once-daily treatment for chronic HBV infection in adults.

The approval of Vemlidy for this pediatric patient population is backed by Week
96 data from a Phase 2 clinical trial that compared treatment with Vemlidy 25 mg
to placebo.



Copyright(c) 2024 RTTNews.com. All Rights Reserved

Copyright RTT News/dpa-AFX