Genvoya tenofovir alafenamide fumarate regulatory update

EMA’s CHMP recommended approval of Genvoya tenofovir alafenamide fumarate (TAF)/elvitegravir/cobicistat/emtricitabine from Gilead to treat HIV infection in patients ages >=12 with a body weight of >=35 kg. An NDA for the single, once-daily tablet containing 10 mg TAF, 150 mg elvitegravir, 150 mg cobicistat and 200 mg emtricitabine to treat HIV infection in adults is under FDA review, with a Nov. 5 PDUFA date. ...