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.