USFDA Approves BMS’s Evotaz™for the Treatment of HIV-1 Infection in Adults

Brand Name: Evotaz™

Molecule: atazanavir 300 mg and cobicistat 150 mg

Combination drug

• Evotaz is the first and only protease inhibitor pharmacoenhanced by cobicistat that is supported by comparative Phase III clinical trial data
• Evotaz is the only protease inhibitor pharmacoenhanced by cobicistat with virologic failure rates as low as 6% [HIV-1 RNA ≥50 copies/mL at 48 weeks: 6% Evotaz arm; 4% Reyataz^®(atazanavir)/ritonavir arm]*

BMS announced today that the U.S. Food and Drug Administration (FDA) has approved Evotaz(atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Evotaz is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences, Inc. Today’s approval offers patients living with HIV an innovative treatment option that delivers proven suppression (HIV-1 RNA <50 copies/mL, 85% Evotaz arm; 87% Reyataz/ritonavir arm) through 48 weeks.

The use of Evotaz in patients who have previously received HIV medication should be guided by their baseline resistance to protease inhibitors.Evotaz and Reyataz do not cure HIV-1 infection or AIDS. Evotaz is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the product components and in combination with certain drugs.

Evotaz is the first and only protease inhibitor pharmacoenhanced by cobicistat that is supported by comparative Phase III trial data (Gilead Sciences, Inc.’s Study 114). The randomized, double-blind clinical trial (N=692) evaluated the efficacy and safety of Reyataz 300 mg with cobicistat 150 mg (the components of Evotaz) (n=344) versus Reyataz 300 mg with ritonavir 100 mg (Reyataz/ritonavir) (n=348), another pharmacokinetic enhancing agent, in combination with emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults. Patients had a baseline estimated CrCL >70mL/min, a mean baseline plasma HIV-1 RNA of 4.8 log₁₀ copies/mL, and a mean baseline CD4+ cell count of 352 cells/mm. At 48 weeks, 85% of patients in the Evotaz arm achieved HIV-1 RNA levels of <50 copies/mL compared to 87% of patients in the Reyataz/ritonavir arm. Low rates of virologic failure (HIV-1 RNA ≥50 copies/mL: 6% Evotaz arm; 4% Reyataz/ritonavir arm) were observed at 48 weeks, making Evotaz the only protease inhibitor pharmacoenhanced with cobicistat with virologic failure rates as low as 6%.

INDICATIONS for Evotaz (atazanavir and cobicistat) and Reyataz ^®(atazanavir)

Evotaz is a fixed dose combination of atazanavir and cobicistat, and is indicated for use with other antiretroviral agents for the treatment of HIV-1 infection in adults.

Reyataz is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and for patients 3 months and older weighing at least 10 kg.