Emtricitabine/tenofovir alafenamide regulatory update

Gilead submitted an NDA to FDA for emtricitabine/tenofovir alafenamide to treat HIV-1 infection in patients ages >=12. Tenofovir alafenamide is a prodrug of tenofovir, the active agent in Gilead’s Viread tenofovir disoproxil fumarate for HIV and HBV infection. The company also markets HIV drug Emtriva emtricitabine, a nucleotide analog reverse transcriptase inhibitor (NRTI). Viread is a nucleotide analog prodrug reverse transcriptase inhibitor. Gilead plans to submit a regulatory application in the EU for the product this quarter. ...