Gilead Sciences Inc. (GILD: Quote) announced it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration or 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 company said that 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).
Gilead entered into an agreement with Janssen R&D Ireland in June 2011 for the development of a fixed-dose combination of cobicistat and darunavir. In October 2011, Gilead announced an agreement with Bristol-Myers Squibb to develop a fixed-dose combination of cobicistat and atazanavir.
Subject to regulatory approval, Janssen and Bristol-Myers Squibb will be responsible for the formulation, manufacturing, registration, distribution and worldwide commercialization of the cobicistat and darunavir fixed-dose combination and the cobicistat and atazanavir fixed-dose combination, respectively.
Cobicistat is Gilead's proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Unlike ritonavir, cobicistat acts only as a pharmacoenhancer and has no antiviral activity.
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by RTT Staff Writer
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