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  editorial note from Jules Levin: BMS is requesting fast track approval for atazanavir. The FDA is required to answer BMS's request within 45-60 days. If the FDA grants fast track approval atazanavir should be approved 6 months from today. If the FDA does not grant fast track approval the drug may not be available until the Fall of 2003. The reasons for considering fast track approval include data from the phase III study showing atazanavir was comparable to efavirenz in terms of the percent undetectable after 48 weeks of study. This study and others have found that lipid and sugar measures don't go up or go up very little in 48 weeks of study with atazanavir. Glucose, cholesterol, and triglycerides did not go up at all or very little in patients who received atazanavir for 48 weeks. For patients with elevated cholesterol and triglycerides this is an important finding because the risk for premature heart disease is a concern as many patients are experiencing elevations in cholesterol and triglycerides. One study has been presented where patients with elevated lipids and on a protease inhibitor switched to atazanavir and saw reduced lipids. In addition, there are two more points. Atazanavir is taken once a day. And, preliminary resistance research found that when resistance to atazanavir develops some patients may be hypersensitive or not resistant to other protease inhibitors. This latter point needs more confirmation with additional studies. I think the major point that supports a fast track review is the need to provide relief for patients with troublesome lipids. Community support of the request for fast track approval could be helpful in getting the FDA to approve it. Immediate access to atazanavir is available through their expanded access program and the telephone number for your doctor to call is listed below.
PRINCETON, NJ - DECEMBER 20, 2002 - Bristol-Myers Squibb Company (NYSE: BMY) today 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.
"Bristol-Myers Squibb is committed to bringing new treatments to patients with HIV/AIDS," said Peter R. Dolan, Chairman and CEO, Bristol-Myers Squibb. "Should atazanavir gain FDA approval, the Company will be the first to provide once-daily HIV medications in all three drug classes - a testament to Bristol-Myers Squibb's leadership in the development of therapies that provide a range of treatment options for people in need."
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. Patients may be enrolled in the EAP through physicians only. Physicians may call 1-877-7BMSEAP (1-877-726-7327) or visit www.ATVEAP.com for more information about the program.
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