Gilead Sciences Inc. of Foster City, California is seeking approval to market a combination of its Truvada drug with Tibotec Pharmaceuticals’ TMC278 as a single-dose daily treatment for HIV infection. If approved, the new single-tablet regimen would be only the second product that contains a complete antiretroviral treatment regimen in a single once-daily tablet, according to the company.
Truvada is a combination of emtricitabine, a nucleoside reverse transcriptase inhibitor that slows the spread of HIV and tenofovir disoproxil that decreases the amount of HIV in the body. TMC278 made by Tibotec Pharmaceuticals is a non-nucleoside reverse transcriptase inhibitor that prevents HIV from entering the nucleus of healthy T-cells.
The Marketing Authorization Application to the European Medicines Agency (EMA) will be reviewed by EMA’s Committee for Medicinal Products for Human Use under the centralized licensing procedure, which, if approved, provides one marketing authorization in all 27 member states of the European Union. A similar application for TMC278 also is being submitted by Tibotec to the EMA for review.
Gilead says this application comes after a 48-week data collection from two phase 3 double-blind, randomized studies. One study evaluated the safety and efficacy of TMC278 in treatment-naive HIV-1 infected adults. A second bioequivalence study conducted by Gilead demonstrated that the formulation of the fixed-dose combination of Truvada and TMC278 achieved the same levels of medication in the blood as the component products dosed simultaneously.
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