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FOSTER CITY, Calif. — Drug maker Gilead Sciences has submitted a regulatory approval application to the Food and Drug Administration for a drug designed to increase the blood levels of certain drugs for HIV.
The company said Thursday it had submitted an application for cobicistat, a "boosting" agent that works with some HIV drugs — specifically Johnson & Johnson's Prezista (darunavir) and Bristol-Myers Squibb's Reyataz (atazanavir) — to enable once-daily dosing. The drug also is a component of Gilead's HIV treatment Quad (cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil fumarate).
The regulatory filing was based on data from a 48-week, phase-3 study in which cobicistat was shown to work as well as Abbott's Norvir (ritonavir) when combined with Reyataz and Gilead's Truvada (emtricitabine and tenofovir disoproxil fumarate).