- Janssen's (JNJ -0.3%) European unit, Janssen-Cilag International NV, submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of a once-daily single-tablet regimen for the treatment of HIV-1 infection in patients at least 12 years old with a minimum body weight of 40 kg.
- The therapy consists of darunavir 800 mg, cobicistat 150, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg in a single tablet. Darunavir is a protease inhibitor, cobicistat a pharmacokinetic enhancer, emtricitabine a nucleoside reverse transcriptase inhibitor and TAF. Janssen licensed the latter three from Gilead Sciences (GILD +0.5%) in December 2014 for a single-tablet regimen.
- Darunavir is currently marketed by Janssen under the brand name PREZISTA. It markets a combo of darunavir and cobicistat in Europe under the brand name REZOLSTA.