Gilead seeks FDA approval for FDC of emtricitabine/tenofovir alafenamide to treat HIV

Tenofovir alafenamide fumarate (TAF) is a nucleotide reverse transcriptase inhibitor (NRTI) and a new prodrug of tenofovir.

This is the company’s second NDA submitted to the FDA for review of two doses of an investigational FDC of emtricitabine and tenofovir alafenamide (200/10mg and 200/25mg) (F/TAF) to treat HIV-1 infection in adults and pediatric patients age 12 years and older, in combination with other HIV antiretroviral agents.

Gilead Sciences Research and Development executive vice-president and chief scientific officer Norbert Bischofberger said: "Gilead has a long history of innovating HIV treatments, and with F/TAF we have the potential to further optimize therapies for HIV patients who face a lifetime of antiretroviral treatment.

"With its high antiviral efficacy and favorable safety profile, F/TAF may offer an improved backbone for a new generation of HIV regimens."

The NDA is based on data from Phase III trials evaluating the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection among treatment-naïve adults, in which the F/TAF-based regimen resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy.

Last November, the company filed an NDA for an investigational once-daily single tablet regimen containing elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and TAF 10mg (E/C/F/TAF).

The FDA has set a target action date of 05 November 2015, under the Prescription Drug User Fee Act.

TAF has showed high antiviral efficacy at a dose less than one-tenth that of the company’s Viread (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.

The company intends to submit a regulatory application for F/TAF in the European Union (EU) in the second quarter of 2015.