CHMP recommends approval of Juluca for HIV type 1.- Janssen + Viiv HealthCare.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir 50mg [ViiV Healthcare UK Ltd]/rilpivirine 25mg [Janssen Sciences Ireland UC]). Dolutegravir / rilpivirine is a single-pill, two-drug regimen 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 strand transfer inhibitor (INSTI).

The CHMP Positive Opinion follows the FDA approval of dolutegravir/rilpivirine in November 2017 and is supported by 48-week data from two pivotal Phase III trials (SWORD-1 and SWORD-2) and a pivotal bioequivalence study. Data from the SWORD-1 and SWORD-2 trials was recently published in The Lancet (5 January, 2018) and showed that the dolutegravir and rilpivirine regimen is non-inferior to three- and four-drug regimens in maintaining virologic suppression (HIV-1 RNA <50 c/mL) through 48 weeks in adults who are infected with HIV-1 and have no resistance, in both pooled and individual analyses of these Phase III 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. The EC’s final decision is anticipated during the second quarter of 2018.