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Home Industry News Bristol-Myers Squibb announces EU approval for single-tablet regimen for HIV-1 infection

Bristol-Myers Squibb announces EU approval for single-tablet regimen for HIV-1 infection

18th December 2007

Bristol-Myers Squibb has announced that the European Commission has given marketing authorisation for the first once-daily single-tablet regiment for virologically suppressed adults infected with HIV-1.

Atripla, developed as part of a joint venture with Gilead Sciences, has been approved for use in the European Union by patients with virologic suppression to HIV-1 RNA levels of less than 50 copies/ml on their current treatment of combination antiretrovirals for over three months.

It includes three compounds, efavirenz, which is developed by Bristol-Myers Squibb and emtricitabine and tenofovir disoproxil fumarat which is marketed by Gilead Sciences.

The application for marketing authorisation for the compound in the European Union was filed by a joint venture known as Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited.

Brian Gazzard, clinical research director at Chelsea and Westminster Hospital, said: “Historically, HIV treatment regimens have been a challenge for many patients since they often combine multiple medications with complex dosing schedules.”

He added that the combination of three proven medications in a single pill marks significant progress in the simplification of dosing for anti-HIV drugs.

Earlier this week, Bristol-Myers Squibb and Gilead announced that they would share responsibility for commercialising Atripla throughout Europe.

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