FDA Gives Thumbs Up to Gilead’s Odefsey

The FDA has approved Gilead’s second TAF-based single-tablet regimen Odefsey for the treatment of HIV infection.

Odefsey is a single-tablet combination of emtricitabine, rilpivirine and tenofovir alafenamide — or TAF — and is designed to treat HIV-1 in patients 12 years of age or older with no history of antiretroviral treatment.

The approval is part of a development and commercialization agreement between Gilead and Janssen established in 2009. Gilead contributed emtricitabine and tenofovir alafenamide, and Janssen contributed rilpivirine.