Gilead Sciences and Bristol-Myers Squibb announced on December 17 that the European Commission has granted full approval of Atripla for use in 27 European Union countries.
Approval of Atripla was recommended in October by the European Medicine Agency’s (EMEA) Committee for Medicinal Products for Human use.
The one-pill, once-daily, fixed-dose combination tablet containing Sustiva/Stocrin (efavirenz), Viread (tenofovir) and Emtriva (emtricitabine) was approved with certain restrictions. It should be used only in patients who have maintained undetectable viral loads (below 50 copies/ml) on their current antiretroviral regimen for at least three months. The commission also cautions that Atripla not be used by people who have experienced virological failure with an earlier treatment combination or who have resistance to any of the drugs in Atripla.
