Print this page    •   Back to Web version of article

FDA Grants Approval of BMS' Reyataz for Combination Therapy in HIV Treatment

June 23, 2003

The Food and Drug Administration approved Bristol-Myers Squibb Co.'s HIV drug Reyataz (atazanavir), indicated to accompany other antiretroviral agents for the treatment of HIV-1 infection.

Reyataz, an azapeptide protease inhibitor, is the first once-daily protease inhibitor approved by the FDA.

Data from Phase II and Phase III studies, which collectively enrolled approximately 2,400 HIV patients, showed that, along with sustained virologic suppression, the drug did not significantly increase cholesterol and triglyceride levels when used in combination therapy.

According to BMS, the recommended dose of Reyataz is 400 mg taken once daily with food in combination with other antiretroviral therapies. The drug will be available in 100-mg, 150-mg and 200-mg doses.

"Reyataz brings unique benefits to people living with HIV/AIDS, including the convenience of once-daily dosing and minimal impact on lipid levels," said Peter Dolan, chairman and chief executive officer of BMS.




This article was provided by U.S. Food and Drug Administration. You can find this article online by typing this address into your Web browser:
http://www.thebody.com/content/art13831.html

General Disclaimer: TheBody.com is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through TheBody.com should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.