BMS Files Reyataz-Cobicistat Combo Tablet NDA For HIV-1

Bristol-Myers Squibb announced the filing of a New Drug Application for the fixed-dose combination tablet of atazanavir sulfate (marketed under the brand name Reyataz) with cobicistat for the treatment of patients with HIV-1.

Reyataz is a protease inhibitor indicated in combination with other antiretroviral agents, most commonly ritonavir, for treatment of HIV-1.  The drug is a once-daily therapy for treatment-naïve and treatment-experienced adult patients as well as pediatric patients six years old and above who have HIV-1.

Cobicistat is an investigative pharmacokinetic enhancer being developed by Gilead Sciences that can increase the level of certain HIV-1 treatments in the blood and helps make these treatments effective.

BMS is seeking approval for the fixed dose combination tablet for use with other antiretroviral agents for the treatment of HIV-1 infection. If approved, atazanavir sulfate and cobicistat combination tablet could bring a new option to patients with HIV-1 who have to take boosting agents in a separate tablet.

“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. 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,” said Calvin J. Cohen, M.D., MPH, director of research of the Community Research Initiative of New England and internist at the Harvard Vanguard Medical Associates. 

Atazanavir sulfate is the only protease inhibitor that has been evaluated with cobicistat in a randomized, double-blind, prospective Phase III clinical trial comparing the safety and efficacy of cobicistat-boosted Reyataz against ritonavir-boosted Reyataz in treatment-naïve adult patients for 48 weeks. Gilead conducted the trial named Study 114, which BMS said may support the clinical use of atazanavir and cobicistat together.

Brian Daniels, SVP of Global Development and Medical Affairs at Bristol-Myers Squibb, said, “Bristol-Myers Squibb is committed to enhancing our 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.”