Gilead Submits NDA for Antiviral Combo Drug
Gilead Sciences, Inc. has submitted a new drug application (NDA) to the US Food and Drug Administration (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 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 (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.
The 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.
Additional F/TAF-based regimens for HIV treatment are currently in development. In December 2014, Gilead announced the expansion of its existing agreements with Janssen Sciences Ireland UC for the development and commercialization of two new investigational once-daily single tablet regimens containing F/TAF. One combines F/TAF with Janssen's rilpivirine. The other regimen contains F/TAF, cobicistat and Janssen's darunavir.
Gilead plans to submit a regulatory application for F/TAF in the European Union in the second quarter of 2015.
Source: Gilead Sciences