The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the Committee for Medicinal Products (CHMP) for Human Use of the European Medicines Agency (EMA) has issued a positive opinion and recommended marketing authorisation for a single pill for HIV-1 treatment.
Dolutegravir/rilpivirine (JULUCA™) is a single-pill, two-drug regimen for HIV-1 treatment in adults who are virologically suppressed and are on a stable antiretroviral regimen for at least six months with no history of virological failure.
Mathai Mammen PhD, global head of Janssen Research & Development, 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.”
Benefitting HIV patients in Europe
Dolutegravir/rilpivirine maintains the efficacy of a traditional three-drug regimen with only two antiretrovirals. If approved, it will be the first single-pill, two-drug regimen that could benefit people living with HIV in Europe.
Dr Josep M Llibre from the Infectious Disease Department at the University Hospital Germans Trias i Pujo, Barcelona, added: “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.
“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.”
What have recent studies shown?
This positive opinion comes after the US Food and Drug Administration’s approval back in November 2017 and is supported by 48-week data from two pivotal Phase III trials (SWORD-1 and SWORD-2) and a bioequivalence study.
Data from the SWORD-1 and SWORD-2 trials, recently published in The Lancet, showed that the dolutegravir and rilpivirine regimen is non-inferior to three- and four-drug regimens in maintaining virologic suppression 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. Virologic suppression rates were similar between treatment arms.
The positive opinion of the CHMP will now be reviewed by the European Commission, which has the authority to grant marketing authorisation for medicines in the European economic area. The commission is expected to make its final decision during the second quarter of this year.