The European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorization for ViiV Healthcare’s 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.”
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 six 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 percent] current antiretroviral regimen 485/511 [95 percent], [adjusted difference -0.2 percent (95 percent confidence interval: -3.0 percent, 2.5 percent), 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 authorization 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.
(Source: ViiV Healthcare)
Filed Under: Drug Discovery