Bristol-Myers Squibb Company announced the submission of a New Drug Application (NDA) to the U.S. 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.
In the United States, Bristol-Myers Squibb is currently enrolling patients in an Early Access Program (EAP) to provide atazanavir to eligible patients infected with HIV. An EAP provides medicines to patients in need of alternative therapy prior to the medicine's approval.
HIV-infected patients who have experienced treatment failure with other available antiretroviral agents and who require an alternative antiretroviral agent in order to construct a new treatment regimen may be eligible to participate in the EAP. Reasons for treatment failure include a sufficient degree of antiretroviral resistance, intolerance or adherence problems. Physicians must use atazanavir in combination with two or more new or recycled antiretroviral agents. In addition, patients must meet other protocol-specified eligibility criteria.