BRISTOL-MYERS SQUIBB SUBMITS NEW DRUG APPLICATION FOR INVESTIGATIONAL
PROTEASE INHIBITIOR ATAZANAVIR FOR TREATMENT OF HIV INFECTION
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
"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.