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news.Gilead Sciences has filed marketing authorization application (MAA) with the European Medicines Agency (EMA) for Quad, a once-daily single-tablet regimen for the treatment of HIV infection.
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The Quad contains four Gilead compounds in a complete once-daily, single-tablet regimen which includes elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
The MAA for the Quad is supported by results from two Phase 3 studies (Study 102 and Study 103).
The MAA is also supported by clinical data for the individual components of the Quad and Chemistry, Manufacturing and Controls information on the individual components of the Quad and the co-formulated single-tablet regimen.