Janssen announced the European Commission has granted marketing authorization for JULUCA (dolutegravir 50mg [ViiV Healthcare]/rilpivirine 25mg [Janssen Sciences Ireland UC]). ViiV Healthcare, as the marketing authorization holder, will market dolutegravir/rilpivirine in all countries in the European Union and European Economic Area.
Dolutegravir/rilpivirine is the first two-drug regimen, once-daily, single-pill for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA
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“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. “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 optimized and individualized treatment options are available for those living with HIV-1.”
Dolutegravir/rilpivirine combines just two antiretrovirals in a single-pill regimen, reducing the cumulative drug exposure in people living with HIV-1, whilst maintaining the efficacy of traditional three-drug regimens at 48-weeks.
“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,” said Dr. Josep M Llibre, Infectious Diseases Dept, University Hospital Germans Trias i Pujol, Badalona, Barcelona.
This approval brings another treatment option to the estimated 810,000 people living with HIV in Europe. It follows the Positive Opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on 22 March 2018. Dolutegravir/rilpivirine was approved by the US Food and Drug Administration (FDA) in November 2017 and Health Canada in May 2018.
Data from two pivotal Phase 3 trials (SWORD-1 and SWORD-2) showed that the dolutegravir and rilpivirine regimen is non-inferior to three- and four-drug regimens in maintaining virologic suppression (HIV-1 RNA
Adverse events were reported by 77% of participants in the dolutegravir+rilpivirine group and 71% in the CAR group. The most commonly reported adverse events were nasopharyngitis (10% dolutegravir+rilpivirine, 10% CAR) and headache (8% dolutegravir+rilpivirine, 5% CAR). Adverse events leading to discontinuation in the dolutegravir+rilpivirine group occurred in 3% of patients and 1% in the CAR group. The safety profiles for dolutegravir and rilpivirine in these studies were consistent with the product labelling for each medicine.