The European Commission has granted marketing authorisation to United Kingdom-based ViiV Healthcare for its Dovato (dolutegravir/lamivudine) that is intended to treat HIV-1 infection, it was reported yesterday.
The product is a new once-daily, single-pill and two-drug regimen approved for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing around 40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.
The approval was based on data from the global Gemini one and two studies that assessed more than 1,400 HIV-1 infected adults.
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