FDA approves Gilead's Odefsey, its second TAF-based single tablet regimen

2 March 2016

The US Food and Drug Administration has approved Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients, with the news sending developer Gilead Sciences’ (Nasdaq: GILD) up 1.9% to $88.92 in afternoon trading yesterday.

Emtricitabine and tenofovir alafenamide are from Gilead and rilpivirine is from Janssen Sciences Ireland, a Johnson & Johnson (NYSE: JNJ) company. Odefsey is Gilead's second TAF-based regimen to receive FDA approval and represents the smallest pill of any single tablet regimen for the treatment of HIV. Last fall, the FDA cleared Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older (The Pharma Letter November 6, 2015).

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