Gilead submits NDA for HIV regimen
Gilead Sciences has submitted a New Drug Application (NDA) to the FDA for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults. If approved, the Quad would be the only once-daily, single-tablet regimen containing an integrase inhibitor.
The NDA is supported by 48-week data from two pivotal phase III studies in which the Quad met its primary objective of non-inferiority as compared to Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (study 102) and to a regimen containing ritonavir-boosted atazanavir (study 103). Complete data from the Quad pivotal studies will be presented at a scientific conference in 2012. The NDA is also supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components of the Quad and the co-formulated single-tablet regimen.