Bristol-Myers Squibb and Gilead will launch their combination HIV therapy within seven business days under the trade name Atripla , despite receiving FDA approval seven months before its projected user fee action date.

The combination of three marketed antiretroviral drugs was approved July 12 for the treatment of HIV-1 in adults either as a stand alone therapy or in combination with other antiretrovirals - less than three months after submission. The agency outlined an expedited approval process for fixed-dose combination and co-packaged HIV therapies in 2004 (¹ Also see "HIV/AIDS NDAs For Fixed-Dose Combination Will Be Exempt From User Fees" - Pink Sheet, 17 May, 2004.).

The fixed-dose therapy combines two Gilead's nucleoside reverse transcriptase inhibitors - Viread (tenofovir disoproxil fumarate 300 mg) and Emtriva (emtricitabine 200 mg) -with Bristol-Myers Squibb's nonnucleoside reverse transcriptase inhibitor Sustiva (efavirenz 600mg), and it represents the first once-daily, single-tablet HIV therapy.

The firms, which established a joint venture to develop a Sustiva/ Truvada (emtricitabine/tenofovir disoproxil) combination product in 2004, announced they had bioequivalence to support Atripla in January (² Also see "Bristol/Gilead HIV Combo Will Go To FDA In Mid-2006" - Pink Sheet, 9 January, 2006.).

Acting FDA Commissioner Andrew von Eschenbach lauded the approval as a model for industry collaboration at a same-day press conference.

"In the future, particularly as molecular medicine continues to emerge, it is clear that solutions to problems like AIDS, like cancer, like Alzheimer's and other diseases will involve the combination of drugs, biologics and devices," von Eschenbach said.

The product will also be made available internationally, where Merck controls the marketing rights of Sustiva.

That "these three companies demonstrated the ability to bring these parts and pieces together into single solution is an important major step forward as a paradigm for the future," von Eschenbach said.

-Brian Marson

Atripla Approved As First Once-Daily, Single-Tablet HIV Therapy

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