Gilead Sciences (GILD) Submits NDA for Cobicistat to FDA

June 28, 2012 4:31 PM EDT
Gilead Sciences, Inc. (Nasdaq: GILD) announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of cobicistat, a 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. Cobicistat is also a component of the Quad once-daily single tablet regimen for HIV, which is currently under U.S. and European regulatory review for treatment-naïve adult patients.

The NDA for cobicistat is supported by 48-week data from a pivotal Phase 3 study (Study 114) in which cobicistat met its primary objective of non-inferiority to ritonavir when both agents were administered with a background regimen of atazanavir sulfate plus Truvada® (emtricitabine and tenofovir disoproxil fumarate). The NDA is also supported by pharmacokinetic data demonstrating that cobicistat boosts blood levels of atazanavir and darunavir similar to ritonavir.

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