By Marie Rosenthal
In a 16-to-2 vote, an FDA advisory committee recommended approval of emtricitabine–tenofovir alafenamide (F/TAF; Descovy Gilead) to be used for pre-exposure prophylaxis (PrEP) to reduce the risk for HIV infection in certain populations, but said there were not enough data to recommend approval for all at-risk individuals.
Gilead is seeking an indication for the oral fixed-dose combination of 200 mg of emtricitabine and 25 mg of tenofovir alafenamide taken once daily for