CHMP issues positive opinion recommending marketing authorisation of Juluca

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 treatment for HIV-1.

Juluca [dolutegravir 50 mg (ViiV Healthcare UK Ltd)/rilpivirine 25 mg (Janssen Sciences Ireland UC)] is a single-pill, two drug regimen for the treatment of HIV-1 infection in adults who are virologically suppressed 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).

“We are delighted to be one step closer to bringing JULUCA to people living with HIV in Europe,” said Dr Mathai Mammen, PhD, global head, Janssen Research & Development, LLC. “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.”

“Approximately two million people in Europe are currently living with HIV. Approval of a single pill, two-drug regimen will reduce the number of antiretrovirals virologically suppressed HIV patients have to take and are exposed to in the long-term, representing a true advancement in HIV care,” said Dr Josep M Llibre, Infectious Diseases Dept, University Hospital Germans Trias i Pujol, Badalona, Barcelona. “The high potency of each drug allows for a low dose of both antiretrovirals and therefore, once approved, JULUCA will be the smallest once-daily single-pill available.”

This positive CHMP opinion follows from the approval of the pill by the US Food and Drug Administration (FDA) back in November last year (2017) and, if approved in Europe, would be the first single pill, two-drug regimen for HIV patients in the region.

It will now be reviewed by the European Commission, which will have the final decision on whether it will receive marketing authorisation for the European Economic Area (EEA). This final decision is expected in the second quarter of this year (2018).