Gilead submits NDA for new HIV treatment to FDA

USA-based Gilead Sciences (Nasdaq: GILD), the world’s leading independent biotech firm, has submitted a New Drug Application to the US Food and Drug Administration for a new HIV treatment.

Gilead has submitted the NDA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide for the treatment of HIV-1 infection in adults and pediatric patients aged 12 years and older, in combination with other HIV antiretrovirals.

Tenofovir alafenamide is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate), and improved renal and bone laboratory parameters as compared to Viread in clinical trials.