European regulators clear ViiV Healthcare's two-drug HIV regimen Juluca

ViiV Healthcare announced Monday that the European Commission approved Juluca (dolutegravir/rilpivirine), making the therapy the first two-drug regimen, once-daily, single-tablet for the treatment of adults with HIV-1 infection 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. 

The approval of Juluca, which follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in March, was supported by efficacy and safety data from two Phase III studies. Results from the SWORD-1 and SWORD-2 trials unveiled in 2016 showed that the therapy met its primary endpoint of non-inferiority in terms of virologic suppression in patients switching from three- or four-drug regimens.  

Juluca, which combines Johnson & Johnson's non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) with ViiV Healthcare's integrase inhibitor Tivicay (dolutegravir), was jointly developed by the drugmakers under an agreement forged in 2014. The two-drug regimen gained FDA approval in November last year. 

The approval comes shortly after regulators in Europe and the US said that they are investigating reports of serious cases of neural tube birth defects involving the brain, spine, and spinal cord in babies born to women treated with GlaxoSmithKline's HIV drug dolutegravir as part of an ongoing observational study. ViiV is majority owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders.

Meanwhile, in April, the CHMP backed approval of Gilead Sciences' Biktarvy, which combines Descovy (emtricitabine/tenofovir alafenamide) with bictegravir, for use in certain adults with HIV-1 infection, with a final decision from the European Commission expected later this year.

For related analysis, see ViewPoints: Why EU approval could be pivotal to success for ViiV, Johnson & Johnson’s Juluca.

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