Gilead's hepatitis B therapy Vemlidy gets EMA nod for use in kids above 6
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A panel of the European Medicines Agency (EMA) recommended the expanded approval of Gilead Sciences' (NASDAQ:GILD) Vemlidy to treat chronic hepatitis B (CHB) in children aged six years and older weighing at least 25 kg.
Vemlidy (tenofovir alafenamide fumarate) is already approved in the EU to treat individuals 12 years and older.

The European Commission (EC), which generally follows the opinion of the EMA's Committee for Medicinal Products for Human Use (CHMP), will now decide on the change to the marketing authorization of the therapy.
In November 2022, the FDA approved the expanded use of the drug 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 U.S. regulator in 2016.