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."