BMS submits new drug application for investigational protease inhibitior atazanavir

Bristol-Myers Squibb (BMS) has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for atazanavir, an investigational protease inhibitor under development for the treatment of HIV/AIDS in combination with other antiretroviral agents.

Atazanavir, currently in phase III clinical development, is an azapeptide viral protease inhibitor of HIV-1. It is the first protease inhibitor to be submitted with pharmacokinetic data supporting the potential for once-daily administration. The NDA includes data from more than 2,400 patients enrolled in clinical trials comparing atazanavir to widely prescribed drugs for HIV infection.