Gilead Sciences Inc. (GILD) announced that the Marketing Authorisation Application or MAA for cobicistat, submitted on April 26, 2012, has been validated by the European Medicines Agency or EMA.
Cobicistat is Gilead's pharmacoenhancing or "boosting" agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing. Currently, ritonavir is the only agent used to boost HIV therapy, the company said.
Gilead said it plans to submit an application for marketing approval of cobicistat to the U.S. Food and Drug Administration in the third quarter of 2012.
Cobicistat is a component of Gilead's investigational Quad single tablet regimen, which also contains elvitegravir, emtricitabine and tenofovir disoproxil fumarate. Cobicistat enables once-daily dosing of elvitegravir within the Quad.
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