Android app on Google Play

Gilead Sciences (GILD) Submits NDA for Cobicistat to FDA

June 28, 2012 4:31 PM EDT Send to a Friend
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.




You May Also Be Interested In


Related Categories

Corporate News, FDA

Add Your Comment