Gilead Sciences Inc. (GILD) announced that it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) or F/TAF for the treatment of HIV-1 infection in adults and pediatric patients age 12 years and older, in combination with other HIV antiretroviral agents.
TAF is a novel nucleotide reverse transcriptase inhibitor or 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.
Today's filing is Gilead's second F/TAF-based NDA submitted to the FDA for review. In November 2014, Gilead filed an NDA for an investigational once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF).
Under the Prescription Drug User Fee Act, the FDA has set a target action date of November 5, 2015. Additionally, a Marketing Authorization Application in the European Union for E/C/F/TAF was fully validated on December 23, 2014.
Gilead noted that it plans to submit a regulatory application for F/TAF in the European Union in the second quarter of 2015.
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