Gilead Sciences, Inc. (Nasdaq:GILD) today 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's 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.
“We are pleased to move one step closer to making this potentially important new simplified treatment option available to physicians and patients in Europe.”
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 expects the European Commission to issue its decision on the marketing authorization for the Eviplera single-tablet regimen later this year.
"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. "We are pleased to move one step closer to making this potentially important new simplified treatment option available to physicians and patients in Europe."
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 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.
Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of the Eviplera single-tablet regimen in July 2009. The product received regulatory approval from the U.S. Food and Drug Administration under the trade name Complera™ (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) in August 2011.