GlaxoSmithKline said Friday that its majority-owned subsidiary, ViiV Healthcare, has submitted a marketing authorization application for a HIV therapy to the European Medicines Agency.
The U.K. pharmaceutical company said the application was submitted for the combined treatment–consisting of dolutegravir and lamivudine–based on the results of the two Gemini studies that included 1,400 adults with the disease.
“This regulatory submission, if approved, will make available a two-drug regimen option with dolutegravir and lamivudine instead of the traditional three-drug regimen and is an important step in the evolution of HIV treatment,” said Deborah Waterhouse, chief executive officer of ViiV Healthcare.
ViiV Healthcare is majority-owned by Glaxo, with Pfizer and Shionogi Limited also holding stakes.
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