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New Drug Application Submitted to FDA for Fixed-Dose Atazanavir/Cobicistat Combo for HIV-1 Patients

Treatment eliminates need for boosting agent in separate tablet

A new drug application (NDA) has been submitted to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz (Bristol-Myers Squibb), and cobicistat (Gilead Sciences), an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain human immunodeficiency virus-1 (HIV-1) medications in the blood and make them more effective.

Bristol-Myers Squibb is seeking approval of the fixed-dose combination tablet for use with other antiretroviral agents for the treatment of HIV-1 infection. If approved, atazanavir sulfate and cobicistat would offer patients with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet.

Reyataz (atazanavir sulfate) is currently indicated in combination with other antiretroviral agents for the once-daily treatment of HIV-1 infection. This is based on analyses of plasma HIV-1 RNA levels and CD4-positive cell counts from controlled studies of 96 weeks (treatment- naïve) and 48 weeks (treatment-experienced) duration in adult and pediatric patients at least 6 years of age.

Approximately 245,000 patients in the U.S. have been treated with Reyataz since its launch in 2003 — nearly twice that of other protease inhibitors launched since that time. Reyataz is currently used in combination with other antiretroviral agents and is most commonly used with ritonavir, a pharmacokinetic enhancer.

Atazanavir sulfate is the only protease inhibitor that has been evaluated with cobicistat in a prospective, randomized, phase III double-blind clinical trial, which compared the efficacy and safety of cobicistat-boosted atazanavir sulfate with that of ritonavir-boosted atazanavir sulfate in treatment-naïve adults for 48 weeks.

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.

Source: Bristol-Myers Squibb; April 14, 2014.

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