In June 2011, Gilead entered into an agreement with Janssen R&D Ireland for the development of a fixed-dose combination of cobicistat and the protease inhibitor darunavir. In October 2011, Gilead also announced an agreement with Bristol-Myers Squibb to develop a fixed-dose combination of cobicistat and atazanavir.Gilead submitted a New Drug Application to FDA for cobicistat on June 28, 2012. On May 23, 2012, the company’s Marketing Authorisation Application for the product was validated for review by the European Medicines Agency (EMA). Cobicistat is also a component of the Quad, a complete single tablet regimen for HIV combining cobicistat with elvitegravir, emtricitabine and tenofovir disoproxil fumarate. The Quad is currently under U.S. and European regulatory review.
Gilead’s Boosting Agent Cobicistat For HIV Therapy As Effective As Ritonavir In Pivotal Phase 3 Study
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