FDA Approves Bristol Myers Squibb's Reyataz

Reyataz is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors.

It prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Reyataz is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). It is not a cure for HIV or AIDS.

Reyataz is an HIV medication. It is in a category of HIV medicines called protease inhibitors (PIs). Reyataz prevents cells infected with HIV from producing new virus. This reduces the amount of virus in your body.

Reyataz, manufactured by Bristol-Myers Squibb, was approved for the treatment of HIV by the U.S. Food and Drug Administration (FDA) in 2003.

Reyataz must be used in combination with at least two other HIV drugs.

Reyataz (atazanavir, BMS-232632) is a type of antiretroviral agent called a protease inhibitor (PI). These medicines block protease, a protein that HIV needs to make more copies of itself.

Reyataz is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Reyataz does not cure HIV or prevent passing HIV to others.

Reyataz Capsules are available for oral administration in strengths containing the equivalent of 100 mg, 150 mg or 200 mg.

Formerly known as BMS-232632, atazanavir/ATV (Reyataz) is an azapeptide protease inhibitor (PI) of HIV-1 protease.

The US Food and Drug Administration (FDA) approved atazanavir on June 20, 2003 for the treatment of HIV-1 infection in combination with other antiretroviral agents.

The FDA based its approval of atazanavir on data from two Phase II 48-week trials and from 24 to 48 week data from Phase III studies. Results from these trials showed a decrease in viral load and an increase in CD4 cell counts in patients taking atazanavir in combination with other antiretroviral agents.

Atazanavir became commercially available in the United States under the principles of the accelerated review process of the FDA that allow approval based on analysis of surrogate markers of response (e.g., plasma HIV-1 RNA levels), rather than clinical end points such as disease progression or survival. There are no results to date from controlled studies evaluating the effects of atazanavir on clinical progression of HIV infection.

Atazanavir is a PI with a unique HIV resistance profile that suggests it may be an appropriate component of antiviral regimens in treatment-naive patients. Patients taking atazanavir on their first antiretroviral regimen develop a characteristic I50L mutation that increases viral susceptibility to other PIs.