Janssen Pharmaceutical Companies and Viiv Healthcare UK have received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for marketing authorisation of Juluca to treat HIV-1 infection.
Juluca is a single-pill, two-drug regimen consisting of 50mg of ViiV Healthcare’s dolutegravir and 25mg of rilpivirine manufactured by Janssen.
Dolutegravir is an integrase strand transfer inhibitor, while rilpivirine blocks non-nucleoside reverse transcriptase enzymes.
The recommendation covers the use of the drug in adults who are virologically suppressed and have been on a stable antiretroviral regimen for a minimum of six months and do not have a history of virological failure.
Janssen Research & Development global head Mathai Mammen said: “We are delighted to be one step closer to bringing Juluca to people living with HIV in Europe.
“Building on our 25-year commitment to make HIV history, this is an important milestone towards continuing to grow our portfolio of treatment options, to help meet the diverse and individual needs of people living with HIV.”
The CHMP positive opinion comes after a review of findings from two Phase III clinical trials and a bioequivalence study.
Results from both trials demonstrated the non-inferiority of the dolutegravir/rilpivirine regimen in sustained virologic suppression through 48 weeks, compared to three and four drug combinations.
The dolutegravir and rilpivirine regimen was approved by the US Food and Drug Administration in November 2017 for the treatment of adults with HIV-1.
ViiV Healthcare UK has also submitted regulatory marketing applications for the regimen in Canada, Australia and Switzerland.