Darunavir/cobicistat/emtricitabine/tenofovir alafenamide regulatory update

Johnson & Johnson’s Janssen-Cilag International N.V. unit submitted an MAA to EMA for a once-daily fixed-dose combination of darunavir/cobicistat/emtricitabine/tenofovir alafenamide to treat HIV-1 infection in patients ages >=12 weighing >=40 kg. The regimen comprises Prezista darunavir, a second-generation protease inhibitor; Tybost cobicistat, an inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A; CYP3); emtricitabine, a nucleoside analog reverse transcriptase inhibitor; and tenofovir alafenamide, a prodrug of tenofovir, a nucleotide analog reverse transcriptase inhibitor. Tybost is a boosting agent for HIV treatment with protease inhibitors. In 2014, Gilead and Janssen partnered to develop the combination. ...