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Gilead Submits New Drug Application for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Infection
Gilead Sciences has submitted a new drug application (NDA) to the FDA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients aged 12 years and older, in combination with other HIV antiretroviral agents.
TAF is a novel nucleotide reverse transcriptase inhibitor 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 compared with those of TDF in clinical trials.
The filing is the second F/TAF-based NDA that Gilead has submitted to the FDA for review. In November 2014, the company 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 set a target action date of November 5, 2015.
The NDA for the F/TAF fixed-dose combination was supported by data from phase III studies that evaluated the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection in treatment-naïve adults, in which the F/TAF-based regimen (administered as E/C/F/TAF) resulted in noninferior efficacy and improved renal and bone laboratory parameters compared with F/TDF-based therapy (administered as E/C/F/TDF [Stribild, Gilead]). The NDA was also supported by data from additional phase III trials that evaluated the F/TAF-based regimen (administered as E/C/F/TAF) in treatment-naïve adolescents, in virologically suppressed adults who switched regimens, and in adults with mild-to-moderate renal impairment. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood that are achieved with E/C/F/TAF.
The recommended dose of F/TAF is 200/25 mg; if it is used in combination with a protease inhibitor that is administered with either ritonavir or cobicistat, the recommended dose is 200/10 mg.
Additional F/TAF-based regimens for the treatment of HIV infection are currently in development. In December 2014, Gilead announced the expansion of existing agreements with Janssen Sciences Ireland UC for the development and commercialization of two investigational once-daily single-tablet regimens containing F/TAF. One regimen combines F/TAF with Janssen’s rilpivirine (Edurant), and the other regimen contains F/TAF, cobicistat, and Janssen’s darunavir (Prezista).
F/TAF-based regimens are investigational products and have not been determined to be safe or efficacious.
Source: Gilead Sciences; April 7, 2015.