Gilead Sciences, Inc. (Nasdaq:GILD)
Gilead Sciences 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.
Gilead Sciences, Inc. (GILD) 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 mission of Gilead Sciences is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead Sciences has operations in North America, Europe and Asia Pacific. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.
For more information about Gilead Sciences, please visit: www.gilead.com
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