The European Commission has granted marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for Juluca (dolutegravir 50mg [ViiV Healthcare]/rilpivirine 25mg [Janssen Sciences Ireland UC]).1 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 <50 c/mL) 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 (NNRTI) or integrase inhibitor (INI).1
The drug regimen combines just two antiretrovirals in a single-pill regimen, reducing the cumulative drug exposure in people living with HIV-1, while maintaining the efficacy of traditional three-drug regimens at 48-weeks.2
“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 department, 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.3 It follows the Positive Opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on 22 March 2018.4 It was approved by the U.S. Food and Drug Administration (FDA) in November 20175 and Health Canada in May 2018.6
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References:
1 Dolutegravir/Rilpivirine European Commission approval details and the full Summary of Product Characteristics will be available on the European Medicines Agency website. [online] Available at: https://www.ema.europa.eu/ema/ [May 2018].
2 Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomized, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018:391:839-849.
3 Pharris A, et al. Estimating HIV incidence and number of undiagnosed individuals living with HIV in the European Union/European Economic Area, 2015. Euro Surveill. 2016 Dec 1; 21(48): 30417.
4 Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency Juluca Summary of Opinion, 2018. [online] Available at: https://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004427/smops/Positive/human_smop_001278.jsp&mid=WC0b01ac058001d127 [Accessed May. 2018].
5 Johnson and Johnson. Janssen Announces U.S. FDA Approval of First and Only Complete, Single-Pill, Two-Drug Regimen, Juluca (Dolutegravir and Rilpivirine), for the Treatment of HIV-1 Infection. Press release November 21, 2017. [online] Available at: https://www.jnj.com/media-center/press-releases/janssen-announces-us-fda-approval-of-first-and-only-complete-single-pill-two-drug-regimen-juluca-dolutegravir-and-rilpivirine-for-the-treatment-of-hiv-1-infection [Accessed May. 2018].
6 Health Canada, Notice of Compliance and Product Monorgraph, “Juluca”, 2018. [Data on file]. [May. 2018].
(Source: Janssen Pharmaceutical Companies of Johnson & Johnson)
Filed Under: Drug Discovery
