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news.Bristol-Myers Squibb and Gilead Sciences have reported that the European Commission has granted marketing authorization for once-daily HIV combination drug, Atripla, for commercialization in the 27 countries of the European Union, as well as in Norway and Iceland.
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Atripla has been approved in the European Union for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels < 50copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harbored virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen. Atripla includes Gilead's Truvada, a combination of drugs Viread and Emtriva, and Bristol-Myers Squibb's Sustiva. Commercial launch of Atripla in the countries of the European Union is not anticipated to begin until the early part of 2008.