- Category: HIV Treatment
- Published on Friday, 28 October 2011 00:00
Gilead Sciences announced this week that it has requested U.S. Food and Drug Administration approval of its 4-in-1 "Quad" combination pill. The Quad combines a complete antiretroviral regimen in a single once daily tablet, containing the new integrase inhibitor elvitegravir boosted with cobicistat (a novel pharmacoenhancer) and tenofovir/emtricitabine (the drugs in Truvada).
Below is an edited excerpt from a company press release describing the New Drug Application submission.
Gilead Submits New Drug Application to U.S. FDA for Once-Daily, Single-Tablet "Quad" HIV Regimen
- Product Would Be Gilead's Third Complete HIV Regimen and the First to Contain an Integrase Inhibitor
Foster City, Calif. -- October 27, 2011 -- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. 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.
About the Quad
The Quad contains four Gilead compounds in a complete once-daily, single-tablet regimen: elvitegravir, an integrase inhibitor; cobicistat, a "boosting" agent that enables elvitegravir once-daily dosing; and Truvada.
Elvitegravir is an integrase inhibitor. Unlike other classes of antiretroviral agents, integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead's agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights.
Cobicistat is Gilead's proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. In addition to studying the agent as part of the Quad, Gilead is also examining cobicistat's potential in boosting commercially available HIV protease inhibitors, which are used in many HIV treatment regimens.
The Quad, elvitegravir and cobicistat are investigational products and their safety and efficacy have not yet been established.
About Gilead Sciences
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 Foster City, California, Gilead has operations in North America, Europe and Asia Pacific. For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences. Gilead Submits New Drug Application to U.S. FDA for Once-Daily, Single-Tablet "Quad" HIV Regimen. Press release. October 27, 2011.