EMA validates Gilead's HIV combo HIV drug application

Gilead Sciences (Nasdaq: GILD), the world’s largest independent biotech firm by sales, says its Marketing Authorization Application (MAA) for two doses of a fixed-dose investigational combination of emtricitabine and tenofovir alafenamide (200/10mg and 200/25mg) (F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA).

The data included in the application support the use of F/TAF for the treatment of HIV-1 infection in adults in combination with other HIV antiretroviral agents. TAF is a novel investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread(tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.

“Therapy innovations have transformed HIV into a chronic condition and people with HIV are living longer, necessitating new treatment options that deliver on both high efficacy and long-term safety,” said Norbert Bischofberger, executive vice president, R&D, and chief scientific officer at Gilead, adding: “F/TAF is the latest advance in Gilead’s long history of innovating in HIV therapy and has the potential to become the backbone for the next generation of HIV regimens.”