European Commission grants marketing authorisation for HIV-1 treatment, Juluca

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the European Commission has granted marketing authorisation for Juluca (dolutegravir/rilpivirine)— a two-drug regimen, once-daily, single pill for the treatment of HIV-1.

“The European Commission Decision for dolutegravir/rilpivirine marks a significant milestone in our 25-year commitment to make HIV history,” said Brian Woodfall, VP, global head Late Development, Infectious Diseases, Janssen Research & Development, LLC. “At Janssen, the driving force behind our R&D efforts is to advance science and to discover and develop transformational medicines that advance health for humanity. We are proud to be combining our internal science with that of others to ensure optimised and individualised treatment options are available for those living with HIV-1.”

“Dolutegravir/rilpivirine signifies an evolution in HIV-1 treatment options by combining two antiretrovirals into a once-daily, single-pill. It maintains the efficacy of a three-drug regimen but reduces the number of antiretrovirals, along with their potential toxicities, that virologically suppressed HIV-1 patients have to take and are therefore exposed to in the long-term,” added Dr Josep M Llibre, Infectious Diseases Dept, University Hospital Germans Trias i Pujol, Badalona, Barcelona.

Marketing authorization holder, ViiV Healthcare, will market the therapy in all countries within the European Union and European Economic Area.

Juluca is the first two-drug regimen, once-daily, single-pill for the treatment of HIV-1, combining two antiretrovirals in a single-pill regimen, reduces the cumulative drug exposure in people living with HIV-1.

Data, published in The Lancet, from two Phase III trials (SWORD-1 and SWORD-2) have demonstrated that the treatment is non-inferior to three- and four-drug regimens in maintaining virologic suppression through 48-weeks in virologically supressed adults who are infected with HIV-1, in both pooled and individual analyses.