Regulatory Affairs

ViiV Healthcare gets EC approval for Juluca to treat HIV-1 infection

PBR Staff Writer Published 22 May 2018

ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer and Shionogi, has secured marketing approval from the European Commission (EC) for Juluca (dolutegravir 50mg/rilpivirine 25mg) to treat human immunodeficiency virus type 1 (HIV-1) infection.

Juluca is a two-drug regimen of ViiV Healthcare’s dolutegravir and Janssen Sciences Ireland’s rilpivirine.

The drug received approval to treat HIV-1 infection in adults, who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no experienced or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.

ViiV Healthcare CEO Deborah Waterhouse said: “The European Commission Decision for Juluca is very positive news for people living with HIV (PLHIV) across Europe, who will now have the opportunity to maintain their viral suppression with a complete treatment regimen composed of only two drugs within a single-pill.”

The approval, which allows to provide the treatment for around 810,000 PLHIV patienst in Europe, is based on the recommendation of the European Medicines Agency’s (EMA) Committee for Human use of Medicinal Products (CHMP) in March this year.

Juluca secured approval from the US Food and Drug Administration in November 2017.  Health Canada also approved the two-drug regimen.

According to GSK, data from the Sword studies, demonstrated that the dolutegravir and rilpivirine regimen is non-inferior to traditional three and four drug regimens in maintaining virologic suppression through 48 weeks in adults who are infected with HIV-1.

In June 2014, ViiV Healthcare collaborated with Janssen Sciences Ireland to assess the potential of combining dolutegravir and rilpivirine in a single tablet to treat HIV patients.

ViiV Healthcare chief scientific and medical officer John Pottage, Jr said: “ViiV Healthcare is committed to delivering innovative advances to meet the unmet needs of PLHIV and our robust clinical research programme has the potential to revolutionalise how we care for PLHIV for the long-term.”