European Commission grants marketing authorization for Gilead’s single tablet regimen Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) for the treatment of HIV

23 June 2016 - Odefsey is the second single tablet regimen containing the Descovy backbone and the third product in Gilead’s new tenofovir alafenamide fumarate portfolio to be approved in Europe.

Gilead Sciences today announced that the European Commission has granted marketing authorization for the once-daily single tablet regimen Odefsey (emtricitabine 200 mg with rilpivirine hydrochloride 25 mg and tenofovir alafenamide fumarate 25 mg) for the treatment of HIV-1 infection in certain patients.

Odefsey combines Gilead’s emtricitabine and tenofovir alafenamide fumarate (marketed as Descovy) with rilpivirine hydrochloride, 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 single tablet regimen based on the Descovy backbone to receive marketing authorization in the European Union and is currently the smallest pill of any single tablet regimen for the treatment of HIV.

For more details, go to: http://www.gilead.com/news/press-releases/2016/6/european-commission-grants-marketing-authorization-for-gileads-single-tablet-regimen-odefsey-emtricitabine-rilpivirine-tenofovir-alafenamide-for-the-treatment-of-hiv

Michael Wonder

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Michael Wonder