ViiV Healthcare announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per 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 or integrase inhibitor.
The 2-drug regimen comprises dolutegravir 50mg (ViiV Healthcare) and rilpivirine 25mg (Janssen Sciences Ireland UC).
Deborah Waterhouse, Chief Executive Officer at ViiV Healthcare commented: “Today is an important milestone for people living with HIV in Europe. It takes us a step closer to offering the first, single-pill, 2-drug regimen with the opportunity to reduce the number of drugs needed to treat HIV in those who are virologically suppressed; Juluca is expected to be the smallest single-pill regimen in the market. ViiV Healthcare is committed to delivering advances in HIV care, including providing innovative treatment options that meet the evolving needs of people living with HIV and we are willing to challenge the traditional HIV treatment paradigms to deliver these advances.”
The CHMP positive opinion follows the United States Food and Drug Administration approval of Juluca in November 2017 for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of dolutegravir/rilpivirine; and is supported by data from two pivotal phase III clinical trials, SWORD-1 and SWORD-2, and a pivotal bioequivalence study.
Positive data from the SWORD studies, recently published in The Lancet (5th January 2018), showed that the dolutegravir and rilpivirine regimen is non-inferior to three and four drug regimens in maintaining virologic suppression (HIV-1 RNA less than 50 copies per mL) through 48 weeks in adults who are infected with HIV-1 and have no history of resistance or treatment failure, in both pooled and individual analyses of the SWORD-1 and SWORD-2 studies (dolutegravir+rilpivirine 486/513 [95%] current antiretroviral regimen 485/511 [95%], [adjusted difference -0.2% (95% confidence interval: -3.0%, 2.5%), pooled analysis]). Virologic suppression rates were similar between treatment arms.
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented: “We believe no one should have to take more medicines than they need, and dolutegravir/rilpivirine represents our first 2-drug regimen that could reduce the number of antiretrovirals people living with HIV in Europe take daily, whilst maintaining the efficacy of traditional three-drug regimens. Our research efforts are exploring a number of two-drug regimen treatment options that look beyond viral load and may address unresolved issues, such as long-term toxicity and reducing the number of drugs used in dosing.”
A CHMP opinion is one of the last regulatory steps before marketing authorisation is granted by the European Commission (EC). The final EC decision on European approval for dolutegravir/rilpivirine is anticipated towards the end of the second quarter of 2018.