Bristol-Myers, Gilead get FDA approval for once-daily HIV tablet

By Elaine Rigoli

Tampa, Fla., July 12 - Bristol-Myers Squibb Co. and Gilead Sciences, Inc. have received Food and Drug Administration approval of Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) for the treatment of HIV-1 infection in adults. It will be available in the United States within seven business days.

The companies said Atripla is the first once-daily single tablet regimen for HIV intended as a stand-alone therapy or in combination with other antiretrovirals.

The product combines Sustiva (efavirenz), manufactured by Bristol-Myers Squibb, and Truvada (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead Sciences.

The collaboration between Bristol-Myers Squibb and Gilead is the first of its kind in the 25-year history of the AIDS epidemic, according to a news release.

On Dec. 20, 2004 the companies established a U.S. joint venture to develop and commercialize the single tablet regimen.

"We appreciate the recognition by the FDA of this important therapeutic advance, and with their approval of Atripla in just over two months, patients will now have rapid access to the first once-daily single tablet regimen for the treatment of HIV-1 infection in adults," Gilead president and chief executive officer John C. Martin said in the release.

Bristol-Myers Squibb is a global pharmaceutical and related health care products company located in New York.

Gilead Sciences is a biopharmaceutical company with headquarters in Foster City, Calif.

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