GlaxoSmithKline’s ViiV Healthcare has received marketing authorisation from the European Commission (EC) for its Triumeq (dolutegravir 50mg/abacavir 600mg/lamivudine 300mg) tablets to treat HIV in adults and adolescents aged 12 years and older and weighing around 40kg.
Triumeq is a once-daily single-pill dolutegravir-based regimen, which combines the integrase strand transfer inhibitor (INSTI) dolutegravir with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.
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ViiV Healthcare CEO Dominique Limet said: "We are delighted with today’s approval that offers people living with HIV in Europe the first single-pill regimen containing dolutegravir."
"Triumeq is a direct result of ViiV Healthcare’s patient-centred approach to innovation. As a company that focuses 100% on HIV, our commitment is to continue to deliver new options for care and treatment for people living with HIV."
The EC has approved Triumeq based on data from two clinical trials, the Phase III study (single) of treatment-naive adults, conducted with dolutegravir and abacavir/lamivudine as separate pills.
The bioequivalence study of the fixed-dose combination of dolutegravir, abacavir and lamivudine has taken a single pill and compared against the administration of dolutegravir and abacavir/lamivudine as separate pills.
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By GlobalDataApproval allows the company to sell the medicine in each European Union member state.
In August, the US Food and Drug Administration (FDA) approved Triumeq, while regulatory applications are filed in other markets such as Australia, Brazil and Canada.
Dolutegravir received approval in the US in August 2013, while in Europe in January under the brand name Tivicay.
Image: Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. Photo: courtesy of C Goldsmith.
