Gilead Submits NDA to FDA for Quad Tablet
Gilead Sciences, Inc. recently announced it has submitted an NDA to the US 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 6 weeks after the unblinding of the second pivotal Phase III study.”
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.
The first single-tablet regimen for HIV, Atripla, was approved in 2006 and is marketed by Gilead and Bristol-Myers Squibb in the
The Quad contains four
Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in
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