Gilead gets FDA nod for hepatitis B drug Vemlidy's use in patients 12 years, above
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The U.S. Food and Drug Administration (FDA) approved the expanded use of Gilead Sciences' (NASDAQ:GILD) Vemlidy (tenofovir alafenamide) as to treat chronic hepatitis B virus (HBV) infection in patients 12 years of age and older with compensated liver disease.

Vemlidy, a prodrug of tenofovir, was previously approved by the FDA in 2016 as a once-daily treatment for adults with chronic HBV infection with compensated liver disease.
The approval of the supplemental new drug application in this pediatric patient population was backed by data from a phase 2 trial (Trial 1092), according to the company.
Gilead noted that Vemlidy has a boxed warning regarding post-treatment severe acute exacerbation of hepatitis B.
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