Gilead Sciences Inc. (GILD) 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.
For comments and feedback contact: editorial@rttnews.com
Business News
April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.