Johnson & Johnson-owned Janssen Pharmaceutical has secured marketing authorisation from the European Commission for the use of its Juluca drug to treat human immunodeficiency virus type-1 (HIV-1) infection.
Juluca is a once-daily, two-drug regimen composed of ViiV Healthcare’s 50mg dolutegravir and 25mg of Janssen’s rilpivirine.
The combination of two antiretrovirals in a single pill is intended to minimise the cumulative drug exposure as well as maintain the efficacy of standard three-drug regimens at 48 weeks.
The indication covers daily use in virologically suppressed adults who were on a stable antiretroviral regimen for a minimum of six months and without history of virological failure and known or suspected resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase inhibitor (INI).
Since ViiV Healthcare is the marketing authorisation holder it will be responsible for the commercialisation of the drug in all countries across the European Union and European Economic Area.
Janssen Research & Development Infectious Diseases, Late Development vice-president and global head Brian Woodfall said: “The European Commission Decision for dolutegravir/rilpivirine marks a significant milestone in our 25-year commitment to make HIV history.
“At Janssen, the driving force behind our R&D efforts is to advance science and to discover and develop transformational medicines that advance health for humanity.”
The approval is supported by results from two Phase III clinical trials during which Juluca is reported to have demonstrated non-inferiority to three and four-drug regimens in maintaining virologic suppression for 48-weeks.
Janssen Sciences Ireland partnered with ViiV Healthcare in June 2014 to investigate whether the combination of dolutegravir and rilpivirine in a single pill could be a treatment option for HIV-1.