Gilead submits NDA for HIV triple therapy

Gilead Sciences Inc. (NASDAQ:GILD) submitted an NDA to FDA for bictegravir/emtricitabine/tenofovir alafenamide to treat HIV-1 infection in adults. The product is a single-tablet, fixed-dose combination of bictegravir (GS-9883), an integrase strand transfer inhibitor (INSTI), emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI), and tenofovir alafenamide, a prodrug of the nucleotide reverse transcriptase inhibitor tenofovir. Next quarter, Gilead plans to submit an MAA to EMA for the combination...