Gilead has filed its next-generation HIV therapy with US regulators, in the hope of providing patients with a lower-dose option with less side effects.
A New Drug Application has been filed with the US Food and Drug Administration seeking approval to market two strengths of a fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for HIV-1 infection in patients aged 12 years and older, alongside other antiretrovirals.
TAF is a novel nucleotide reverse transcriptase inhibitor that has shown high antiviral efficacy at a dose less than one-tenth that of Gilead’s veteran HIV therapy Viread (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters.
“With F/TAF we have the potential to further optimise therapies for HIV patients who face a lifetime of antiretroviral treatment,” said Norbert Bischofberger, Gilead’s chief scientific officer. “With its high antiviral efficacy and favourable safety profile, F/TAF may offer an improved backbone for a new generation of HIV regimens,” he said.
Gilead said it is planning to submit a regulatory application for F/TAF in the European Union in the second quarter of 2015.