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14 May 2012

FDA Committee Votes in Favour of Quad Approval

Gilead Sciences has announced that a US FDA committee has voted to support the approval of the Quad regimen and Truvada.

An advisory committee of the US Food and Drug Administration (FDA) has voted in favour of approving Gilead's once-daily single tablet regimen for HIV, called the 'Quad'.


The Quad contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate and is designed to treat HIV-1 infection in treatment-naive adults.


Members of the Antiviral Drugs Advisory Committee voted 13 to one in support of the treatment's approval, which will be considered by the FDA as it completes its review of the therapy later this year.


Gilead has also submitted applications for marketing approval in the European Union, Canada and Australia.


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