Genvoya tenofovir alafenamide fumarate regulatory update

FDA approved an NDA from Gilead for Genvoya tenofovir alafenamide fumarate/elvitegravir/cobicistat/emtricitabine from Gilead to treat HIV-1 infection in patients ages >=12. Gilead launched the drug at an annual wholesale acquisition cost (WAC) of $31,362. In September, EMA’s CHMP recommended approval of Genvoya, which is a single, once-daily tablet containing 10 mg TAF, 150 mg elvitegravir, 150 mg cobicistat and 200 mg emtricitabine. ...