Summaries of health policy coverage from major news organizations
FDA Report Says Bristol-Myers Squibb’s Antiretroviral Drug Atazanavir is Safe, Effective
Bristol-Myers Squibb's experimental antiretroviral drug atazanavir is safe and effective for treating HIV infection, according to an FDA report released in advance of an agency advisory panel meeting scheduled for today, the Bloomberg News/New York Times reports (Bloomberg News/New York Times, 5/13). The panel is expected to discuss concerns that atazanavir causes heart or liver damage and will decide whether to recommend approval for the drug, according to Reuters. If it is approved, atazanavir, which is also known by the brand name Reyataz, would be the first once-a-day protease inhibitor approved for marketing. According to BMS, the drug would simplify HIV/AIDS drug regimens. The advisory board will also consider whether atazanavir raises cholesterol levels like some other antiretroviral drugs. Atazanavir could have "a unique advantage" over other antiretroviral drugs if it is shown not to raise cholesterol levels, according to Reuters. Shaojing Tong, an analyst with Mehta Partners, said that the advisory board will likely recommend that the FDA approve the drug, according to Reuters. He added that sales of the drug could reach $700 million to $800 million, "a pretty significant number for Bristol-Myers," according to Reuters (Richwine, Reuters, 5/12).
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