FDA Approves Bristol-Myers Squibb’s Once-Daily Antiretroviral Drug Atazanavir

The FDA on Friday approved Bristol-Myers Squibb's antiretroviral drug atazanavir, the Wall Street Journal reports (Landers, Wall Street Journal, 6/23). Atazanavir, which is also known by the brand name Reyataz, is the first once-a-day protease inhibitor approved for marketing. According to BMS, the drug will simplify HIV/AIDS drug regimens (Kaiser Daily HIV/AIDS Report, 5/13). The drug, which is to be used in combination with other antiretroviral drugs, was approved on results from two 48-week Phase II clinical trials and from 24-week to 48-week findings from Phase III studies. The studies showed a reduction in viral load and an increase in CD4+ T cell counts in patients taking the drug in combination with other antiretrovirals. The results were found both in patients who had never been treated with antiretrovirals and in patients who had previously taken other drugs (FDA release, 6/20). Clinical trials of the drug showed that it can fight HIV infection without "significantly" raising cholesterol levels, compared with some other HIV/AIDS drugs that are associated with increased cholesterol levels, the Journal reports. James Palmer, head of research and development at BMS, said that cholesterol levels are important due to a "potential epidemic of coronary artery disease" among people living with HIV (Wall Street Journal, 6/23). There are currently six other protease inhibitors approved by the FDA for use in the United States (FDA release, 6/20).