April 22, 2014
BMS Files for FDA Approval of Reyataz/Cobicistat Combo Pill
Bristol-Myers Squibb (BMS) has filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for a fixed-dose combination tablet of Reyataz (atazanavir) and cobicistat for the treatment of HIV. The latter drug is an investigational pharmacokinetic enhancer, or boosting agent, that’s similar to Norvir (ritonavir) in that it can increase blood levels of certain antiretrovirals.
Reyataz, a protease inhibitor that was approved in 2003 and has been prescribed to about a quarter of a million people with HIV since then, is often paired with Norvir as a boosting agent.
“Bristol-Myers Squibb is committed to enhancing our existing regimens, as well as developing new therapies to make HIV treatment simpler for patients,” Brian Daniels MD, senior vice president of global development and medical affairs at BMS, said in a release. “The submission of this NDA represents an important step forward in our efforts to provide patients with new options for Reyataz treatment.”
The two drugs were studied in a prospective, randomized, Phase III double-blind clinical trial that compared the safety and efficacy of cobicistat-boosted Reyataz with Norvir-boosted Reyataz in treatment-naive people with HIV over a course of 48 weeks.
“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,” Calvin J. Cohen, MD, MPH, director of research at the Community Research Initiative of New England and an internist at Harvard Vanguard Medical Associates, said in a release. “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.”
BMS, which manufactures Reyataz, has entered into a licensing agreement with Gilead Sciences, which makes cobicistat, to develop and market the combination tablet.
To read the release, click here.
Search: Bristol-Myers Squibb, BMS, Reyataz, cobicistat, atazanavir, ritonavir, boosting agent, U.S. Food and Drug Administration, FDA, Norvir, new drug application, Brian Daniels, Calvin J. Cohen.
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