EC OKs Gilead’s HIV Combo Drug OdefseyBy
The European Commission has granted marketing authorization for Gilead Sciences’ 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, according to the company.
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.
TAF is al targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's Viread (tenofovir disoproxil fumarate).
The Odefsey approval is part of an ongoing development and commercialization agreement between Gilead and Janssen, first established in 2009. Under this agreement, Gilead is responsible for the manufacturing, registration, distribution, and commercialization of Odefsey in most countries while Janssen will distribute it in approximately 18 markets and have co-detailing rights in several key markets, including the United States. The original agreement was established for the development and commercialization of Eviplera, marketed as Complera in the United States, and was expanded in 2014 to include Odefsey.
Source: Gilead Sciences