Gilead Sciences announce it has submitted a New Drug Application (NDA) to the FDA for marketing approval of cobicistat as a boosting agent for protease inhibitors in HIV therapy to enable once-daily dosing.
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). In addition, the NDA is supported by pharmacokinetic data demonstrating that cobicistat boosts blood levels of atazanavir and darunavir similar to ritonavir.
Cobicistat is a mechanism-based inhibitor of cytochrome P450 3A (CYP3A). 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.
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