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BMS Submits NDA for a Fixed-Dose Combination Tablet of Atazanavir Sulfate with Cobicistat for HIV-1

Mon, 04/14/2014 - 8:18am

Bristol-Myers Squibb Company announced today the submission of a new drug application (NDA) on April 4, 2014 to the 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. Bristol-Myers Squibb is seeking approval of the fixed-dose 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. Cobicistat is being developed by Gilead Sciences, Inc.

Approximately 245,000 patients in the U.S. have been treated with Reyataz since its launch in 2003, nearly twice that of any other protease inhibitor launched since that time. Reyataz is currently used in combination with other antiretroviral agents and is most commonly used with ritonavir, a pharmacokinetic enhancer. A once-daily therapy, Reyataz is indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adult patients and pediatric patients six years of age or older.

“Bristol-Myers Squibb is committed to enhancing our existing regimens, as well as developing new therapies to make HIV treatment simpler for patients,” said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “The submission of this NDA represents an important step forward in our efforts to provide patients with new options for Reyataz treatment.”

Reyataz is the only protease inhibitor that has been evaluated with cobicistat in a prospective, randomized, Phase III double-blind clinical trial (Gilead’s Study 114), which compared the efficacy and safety of cobicistat-boosted Reyataz (atazanavir sulfate) versus ritonavir-boosted Reyataz in treatment-naïve adult patients for 48 weeks. Study 114 may support the clinical use of atazanavir and cobicistat together.

“Adhering to HIV treatment regimens can be challenging for some patients, and if the prescribed medications are not taken properly, it could result in treatment failure,” said Calvin J. Cohen, M.D., MPH, director of research, Community Research Initiative of New England and internist, Harvard Vanguard Medical Associates. “If approved by the FDA, a once-daily, fixed-dose combination of atazanavir sulfate and cobicistat would offer patients living with HIV-1 another treatment option.”

In October 2011, Bristol-Myers Squibb announced 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. Under the terms of the agreement, 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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