Bristol-Myers Squibb Company BMY announced today the submission of a
new drug application (NDA) on April 4, 2014 to the U.S. Food and Drug
Administration (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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