London's ViiV Healthcare Ltd. said the European Commission granted marketing authorization to Juluca for treating certain patients with HIV-1 infection.
Juluca is a 2-drug, single pill regimen which brings together ViiV's dolutegravir, known in single-tablet form as Tivicay, and rilpivirine, sold individually as Edurant by Johnson & Johnson.
The authorization comes almost a month after the European Medicines Agency's Committee for Medicinal Products for Human Use granted a positive opinion to the therapy. Juluca is already approved in the U.S. and Canada.
Juluca aims to address pill fatigue, a problem among HIV patients who often take multiple medications a day.
ViiV's Juluca is the first treatment with a reduced-drug regimen to reach the market for HIV-1 patients, outracing its rival Gilead Sciences Inc.
ViiV Healthcare was established in November 2009 by GlaxoSmithKline PLC, which holds a majority stake in the company, and Pfizer Inc.
Japan's Shionogi & Co. Ltd. is also a shareholder in ViiV.