EU approves Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection.- Gilead Sciences
Gilead Sciences, Inc.has announced that the European Commission has granted marketing authorization for the once-daily single tablet regimen (STR) Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. Odefsey combines Gilead�s emtricitabine and tenofovir alafenamide (marketed as Descovy) with rilpivirine, marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Following the approval of Genvoya in November 2015, Odefsey is Gilead�s second STR based on the Descovy backbone to receive marketing authorization in the European Union and is currently the smallest pill of any STR for the treatment of HIV.
Odefsey is indicated in the European Union for the treatment of adults and adolescents (ages 12 years and older with body weight at least 35 kg) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load less than 100,000 HIV-1 RNA copies/ml.
Related news and insights
Medtronic announced the United States launch of the Penditure left atrial appendage (LAA) exclusion system, an implantable clip preloaded on a single-use delivery system for LAA management during concomitant cardiac surgery procedures
GSK plc announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma