The European Commission has granted marketing approval to ViiV Healthcare, a joint venture of GlaxoSmithKline, Pfizer and Shionogi, for Juluca (dolutegravir 50mg/rilpivirine 25mg) intended to treat human immunodeficiency virus type 1 infection, it was reported yesterday.
The product is a two-drug regimen of the company's dolutegravir and Janssen Sciences Ireland's rilpivirine.
The drug received approval to treat HIV-1 infection in adults, who are virologically suppressed on a stable antiretroviral regimen for around six months with no history of virological failure and no experienced or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor. The approval enables the provision of treatment for around 810,000 PLHIV patients in Europe. It is based on the recommendation of the European Medicines Agency's (EMA) Committee for Human use of Medicinal Products (CHMP) in March this year.
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