Biopharma Business

Janssen has announced that the European Commission (EC) has approved its darunavir-based single-tablet regimen (STR), Symtuza▼, for the treatment of HIV-1 in adults and adolescents in Europe.

“Today’s decision by the European Commission to approve the use of darunavir-STR validates our efforts to treat HIV more simply, addressing the issues of adherence and resistance,” said Dr Frank Wiegand, medical director, Janssen UK. “At Janssen, we are committed to developing effective and innovative treatments which address these issues, while helping all those living with HIV to achieve an undetectable viral load and ultimately enjoying an improved quality of life.”

Data from a bioequivalence study comparing darunavir-STR with the combined administration of the separate agents in a fixed dose combination were presented during the International AIDS Society (IAS) conference in Paris. The results of this study confirmed that the once-daily STR is bioequivalent to the combined administration of the separate agents, as well as demonstrating that the STR is well tolerated.

Additionally, data from the Phase III EMERALD trial, also presented at the event, showed that the once-daily STR had a low cumulative virologic rebound rate and a high virologic suppression rate at 24 weeks in HIV-1 positive, virologically suppressed adults who switched from a boosted protease inhibitor (PI) regimen. A Phase III clinical trial programme investigating the efficacy and safety of the darunavir-based combination is ongoing.

Earlier this year, the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for darunavir-STR. With this approval from the EC, Janssen can now market darunavir-STR in all 28 European Union countries as well as in the three European Economic Area countries.