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news.Bristol-Myers Squibb and Gilead Sciences have submitted an application to the FDA for approval of a product that combines the anti-HIV medications Sustiva, manufactured by BMS, and Truvada, manufactured by Gilead, in a once-daily single tablet regimen.
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Truvada itself is a fixed-dose product that contains two of Gilead’s anti-HIV medications, Viread and Emtriva, 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 (HAART) 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.
On December 20, 2004 the companies established a US joint venture to develop and commercialize the single tablet regimen in the US. Subject to marketing approval, BMS and Gilead will share responsibility for commercializing the product in the US.
“Bristol-Myers Squibb is pleased to partner with a company that, like us, values scientific and commercial innovation to help patients,” said Anthony Hooper, president of US pharmaceuticals at BMS. “The collaboration between the companies is an important milestone for patients living with HIV.”