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news.Bristol-Myers Squibb (BMS) has submitted a new drug application (NDA) to the US 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, for the treatment of HIV-1 infection.
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The company is seeking approval of the fixed-dose combination (FDC) tablet for use in combination with other antiretroviral agents to treat patients with HIV-1.
Developed by Gilead Sciences, cobicistat is designed to increase the level of certain HIV-1 medicines in the blood and make them more effective.
If approved, the combination could offer patients living with HIV-1 a single tablet that reduces the need to take a boosting agent in a separate tablet.
Bristol-Myers Squibb senior vice president of Global Development and Medical Affairs Brian Daniels said the company is committed to improving its existing regimens, as well as developing new therapies to make HIV treatment simpler for patients.
"The submission of this NDA represents an important step forward in our efforts to provide patients with new options for Reyataz treatment," Daniels said.
The company said that 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).
The trial compared the efficacy and safety of cobicistat-boosted Reyataz versus ritonavir-boosted Reyataz in treatment-naïve adult patients for 48 weeks.
Image: A Bristol-Myers Squibb R&D facility Princeton Rd, Princeton, New Jersey, US. Photo: courtesy of Coolcaesar