Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults. Pending approval, the new single-tablet regimen would be only the second product that contains a complete antiretroviral treatment regimen in a single once-daily tablet.
“The important role of complete, fixed-dose HIV treatment regimens is well established in Europe”
The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP). Review of the MAA will be conducted by the EMA under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 27 member states of the European Union. An MAA for TMC278 also is being submitted today by Tibotec to the EMA for review.
"The important role of complete, fixed-dose HIV treatment regimens is well established in Europe," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. "Today, nearly one quarter of HIV patients in the major European countries are taking a one pill, once-daily regimen, and recent updates to the International AIDS Society guidelines support the use of these simplified regimens. We are pleased to work with Tibotec in contributing another potentially important new once-daily, fixed-dose treatment option."
The regulatory application for the fixed-dose combination is supported by 48-week data from two Phase III double-blind, randomized studies (ECHO and THRIVE) evaluating the safety and efficacy of TMC278 in treatment-naive HIV-1 infected adults and a bioequivalence study conducted by Gilead, which 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. ECHO (Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and Efavirenz) evaluated TMC278 (25 mg) combined with a fixed-dose background regimen consisting of emtricitabine (200 mg) and tenofovir disoproxil fumarate (245 mg). THRIVE (TMC278 against HIV, in a once-daily RegImen Versus Efavirenz), evaluated once-daily TMC278 (25 mg) compared to once-daily efavirenz (600 mg) combined with an investigator-selected background regimen consisting of two nucleoside reverse transcriptase inhibitors (abacavir and lamivudine, or emtricitabine and tenofovir disoproxil fumarate, or zidovudine and lamivudine).
Gilead entered into a license and collaboration agreement with Tibotec Pharmaceuticals for the development and commercialization of a single-tablet regimen containing TMC278 and emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV in July 2009. In April 2010, Gilead announced that it had successfully formulated and obtained data supporting bioequivalence of the fixed-dose combination.
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