Gilead submits new drug application to USFDA for HIV regimen

Product would be Gilead’s third complete HIV regimen and the first to contain an integrase inhibitor

Gilead Sciences, Inc announced today that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (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.

“We continue to dedicate our HIV research and development efforts to advancing single-tablet regimens that address important patient needs,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Based on data from our pivotal studies, we believe that the Quad has the potential to be an important new treatment option for people living with HIV, and we are pleased to have reached this significant milestone less than six weeks after the unblinding of the second pivotal Phase 3 study.”

The NDA is supported by 48-week data from two pivotal Phase 3 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.

The first single-tablet regimen for HIV, Atripla, was approved in 2006 and is marketed by Gilead and Bristol-Myers Squibb in the United States. The company’s second single-tablet regimen, Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), which combines Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ rilpivirine, was approved in the United States in August 2011.