B-MS and Gilead enter deal for HAART tablet

Drug major Bristol-Myers Squibb and fellow USA-based Gilead Sciences have submitted a New Drug Application to the Food and Drug Administration for approval of a product that combines the former's anti-HIV medications Sustiva (efavirenz) and Truvada (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead Sciences, in a once-daily, single-tablet regimen.

Truvada itself is a fixed-dose product that contains two of Gilead's anti-HIV medications, Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine), in a single once-daily tablet. If approved by the FDA, the new single tablet regimen would be the first and only product that contains a complete highly-active antiretroviral therapy regimen in a single once-daily tablet, intended for the treatment of HIV-1 infection in adults as a complete regimen or in combination with other antiretrovirals. According to the two firms, the work necessary to file the NDA, including bioequivalence studies and the initiation of stability studies, has now been completed.