Gilead's STR Odefsey Granted EU Marketing Authorization For Treatment Of HIV

(RTTNews) - Gilead Sciences, Inc. (GILD) said that the European Commission has granted marketing authorization for the once-daily single tablet regimen or 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.

In the European Union, Odefsey is indicated for the treatment of adults and adolescents, aged 12 years and older with body weight at least 35 kg, without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor or NNRTI class, tenofovir or emtricitabine, and with a viral load less than 100,000 HIV-1 RNA copies/ml.

Gilead noted that the marketing authorization for Odefsey is supported by a bioequivalence study demonstrating that Odefsey achieved similar drug levels of emtricitabine and TAF in the blood as Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg; E/C/F/TAF) and similar drug levels of rilpivirine as Edurant, or rilpivirine 25 mg.