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Gilead files HIV combo drug with FDA

Gilead has submitted an application to the US Food and Drug Administration for a complete antiretroviral HIV treatment regimen in a single pill

Gilead Sciences has submitted a marketing application to the US Food and Drug Administration (FDA) for a product intended to offer patients a complete antiretroviral HIV treatment regimen in a single pill.

The once-daily, fixed-dose pill combines Gilead's Truvada (emtricitabine and tenofovir disoproxil fumarate) with Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor, TMC278 (rilpivirine hydrochloride) to treat HIV-1 infection in treatment-naïve adults.

The submission for Truvada/TMC278 is supported by a bioequivalence study showing that the formulation of the single-tablet regimen achieved the same levels of medication in the blood as the separate products dosed together as individual pills.

If approved, the combination product will become only the second once-daily, single-pill antiretroviral regimen marketed in the US. The first, Atripla, was approved by the FDA in 2006 and is marketed by Bristol-Myers Squibb and Gilead. That drug is a combination of Sustiva (efavirenz), Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate).  

Tibotec submitted its US marketing application for TMC278 in July, seeking approval of the drug for once-daily use with other antiretroviral agents. In the EU, Gilead and Tibotec filed marketing applications for TMC278 and for the Truvada/TMC278 single-tablet regimen in early September.

The combination product is the result of a license and collaboration agreement that the two companies signed in late July 2009.

The deal calls for Gilead to take the lead role in manufacturing, registration, distribution and commercialisation of the single-tablet regimen worldwide, excluding the developing world and Japan. Tibotec will be responsible for the commercialisation of TMC278 as a stand-alone product and has rights to co-promote the single-tablet regimen in the developing world and Japan.

25th November 2010

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