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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.

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