FDA Approves Gilead's HIV Drug Complera
The approval of Complera is supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies.
Biopharmaceutical company Gilead Sciences, Inc. announced Wednesday that the U.S. FDA has approved Complera? (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-na?ve adults.
Complera combines three antiretroviral medications in one daily tablet – Gilead's Truvada?, which is a fixed-dose combination of the two nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate, and Tibotec Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor, rilpivirine (marketed as Edurant? in the United States by Janssen Therapeutics, Division of Janssen Products, LP).
Truvada and rilpivirine were approved by the FDA in August 2004 and
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