ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, announced that the European Commission has granted marketing authorisation for Juluca.
Juluca (dolutegravir 50mg/rilpivirine 25mg) was approved for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.
Juluca is a 2-drug regimen of dolutegravir (ViiV Healthcare), the most widely prescribed integrase inhibitor worldwide, and rilpivirine (Janssen Sciences Ireland UC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson).
This approval brings another treatment option to the estimated 810,000 PLHIV in Europe. It follows the Positive Opinion from the European Medicines Agency’s (EMA) Committee for Human use of Medicinal Products (CHMP) on 22 March 2018. Juluca was approved by the US Food and Drug Administration (FDA) in November 2017 and Health Canada on 18 May 2018.