EMA panel recommends extending indication for Gilead's HIV drug Biktarvy to include kids
Justin Sullivan


The European Union drug regulator's human medicines committee has recommended a new dosage strength for Gilead Sciences' (NASDAQ:GILD) HIV drug Biktarvy and an extension of its indication, according to the highlights of their latest meeting released on Friday.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the addition of a new strength for Biktarvy as 30 mg/120 mg/15 mg film-coated tablets.
The CHMP also recommended extending the indication of the drug to be used as a treatment for HIV in children from two years of age.
Accordingly, the full indication for Biktarvy as recommended by the CHMP would be for the treatment of HIV-1 infection in adults and pediatric patients at least 2 years of age and weighing at least 14 kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
The CHMP on Friday also backed the expanded use of Gilead's (GILD) COVID-19 drug Veklury and cancer therapy Yescarta.
GILD stock -0.4% to $64.75 in premarket trading.