“There is a need for the simplification of treatment regimens featuring co-formulated, fixed-dose medicines as patients stay on therapy longer,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences, Inc. (Nasdaq:GILD), a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.



Gilead Sciences yesterday announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorisation Application for the once-daily single-tablet regimen, Eviplera®, combining Gilead Sciences' Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) with Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor Edurant® (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in antiretroviral-naïve adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/mL.

The CHMP’s positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union (EU). Gilead Sciences expects the European Commission to issue its decision on the marketing authorization for the Eviplera single-tablet regimen later this year.

The regulatory filing for the Eviplera single-tablet regimen is supported by 48-week data from two Phase 3 double-blind, active controlled, randomized studies (ECHO and THRIVE) conducted by Tibotec evaluating the safety and efficacy of rilpivirine compared to efavirenz in treatment-naïve HIV-1 infected adults. Both arms of the studies were administered with a background regimen, in which the majority of patients in the rilpivirine arm received Truvada. A bioequivalence study conducted by Gilead Sciences demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate.

For more information about Gilead Sciences, please visit: www.gilead.com

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