FOSTER CITY (dpa-AFX) - Bristol-Myers Squibb Company (BMY) announced it has submitted a new drug application (NDA) to the U.S. FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective. The company is seeking approval of the combination tablet for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet, the company said. Cobicistat is being developed by Gilead Sciences, Inc.
In 2011, Bristol-Myers Squibb signed a licensing agreement with Gilead for the development and commercialization of a once-daily, single tablet fixed-dose combination product of atazanavir sulfate and Gilead's cobicistat. Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the atazanavir sulfate and cobicistat fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
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