J&J receives European approval for single tablet HIV regimen

Johnson & Johnson’s pharmaceuticals subsidiary Janssen has announced that the European Medicines Agency has approved the single tablet regimen (STR) Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) for the treatment of certain HIV patients.

The therapy combines J&J’s own darunavir, marketed as monotherapy under the name Prezista, with Gilead Sciences’ cobicistat, emtricitabine and tenofovir alafenamide.

Symtuza is the only darunavir-based STR approved for the treatment of the indicated patient group.

The application was supported by results from a study that confirmed bioequivalence to the combined administration of the separate agents, as well as demonstrating that the STR is well tolerated.

The company has also announced positive Phase III data from the EMERALD and AMBER trials, details from which will be presented at upcoming scientific meetings.