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news.Gilead Sciences has submitted a New Drug Application (NDA) to the US FDA for marketing approval of the Quad, a single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate to treat HIV-1 infection in adults.
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Following approval, the Quad will be the only once-daily, single-tablet regimen containing an integrase inhibitor.
The submission of NDA was done on the back of positive data from two Phase 3 studies in which the Quad met its primary objective of non-inferiority.
Gilead Sciences Research and Development executive vice president and chief scientific officer Norbert Bischofberger said the Quad could evolve as a new treatment option for HIV and the company has reached an important milestone soon after the unblinding of the second Phase 3 study.