European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1...( - Product Developed Through Joint Ve...),Health

- Product Developed Through Joint Venture Between Bristol-Myers Squibb and

Gilead Sciences, the First of Its Kind in HIV Treatment -

PRINCETON, N.J. and FOSTER CITY, Calif., Dec. 17 /PRNewswire-FirstCall/ -- The European Commission has granted marketing authorization for ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), formally approving ATRIPLA for commercialization in the 27 countries of the European Union, as well as in Norway and Iceland.

"Historically, HIV treatment regimens have been a challenge for many patients since they often combine multiple medications with complex dosing schedules," said Brian Gazzard, MD, Clinical Research Director, Chelsea and Westminster Hospital, London. "ATRIPLA combines three clinically proven and well-established anti-HIV medicines in a single once-daily pill and represents an important step forward in dosing simplification."

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 < 50 copies/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.

Efavirenz is marketed by Bristol-Myers Squibb Company (NYSE: BMY) under the tradename SUSTIVA(R) in the United States, Canada and six European countries (France, Republic of Ireland, Germany, Italy, Spain and the United Kingdom). Efav
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