FDAnews Drug Daily Bulletin

BMS, GILEAD SUBMIT NDA FOR HIV TREATMENT

May 8, 2006
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Bristol-Myers Squibb (BMS) and Gilead Sciences have submitted a new drug application (NDA) to the FDA for a product that combines two anti-HIV medications in a once-a-day single tablet regimen.

According to the announcement, this product would be the "first and only product that contains a complete Highly Active Antiretroviral Therapy (HAART) regimen in a single one-daily tablet." The result of a joint venture established in 2004, the single regimen is intended for the treatment of HIV-1 in adults either on its own or with other antiretrovirals.

The tablet is a combination of Bristol-Myers' Sustiva (efavirenz) and Gilead's Truvada (emtricitabine and tenofovir disoproxil fumarate). The three active ingredients block reverse transcriptase, an enzyme necessary for HIV replication.

The companies' announcement states that HHS lists the combination of the three drugs as "one of the preferred non-nucleoside reverse transcriptase inhibitor (NNRTI)-based treatment regimens for use in appropriate patients who have never taken anti-HIV medicines before."