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European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
Date:10/18/2007

- Once Granted by the European Commission, ATRIPLA Would Represent the First and Only Once-Daily Single Tablet Regimen for Many HIV/AIDS Patients

in the European Union -

PRINCETON, N.J., FOSTER CITY, Calif. and WHITEHOUSE STATION, N.J., Oct. 18 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY), Gilead Sciences, Inc. (Nasdaq: GILD) and Merck & Co., Inc. (NYSE: MRK) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion on the Marketing Authorisation Application for ATRIPLA(R) (efavirenz 600mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Specifically, the CHMP has recommended ATRIPLA for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of < 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 an
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SOURCE Bristol-Myers Squibb
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