Health Canada approves HIV drug Odefsey

Medicines regulator Health Canada has granted a Notice of Compliance (NOC) for Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) tablets as a complete regimen for the treatment of adults with HIV-1 infection.

Odefsey is the most recent product approved for the Canadian subsidiary of Gilead Sciences’ (Nasdaq: GILD) range of tenofovir alafenamide (TAF)-based regimens that include Genvoya and Descovy. Odefsey was cleared for marketed in the USA and Europe and March and June of last year, respectively.

In Canada, Odefsey is indicated as a complete regimen for the treatment of adults infected with HIV-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and who have HIV-1 RNA levels less than or equal to 100,000 copies per mL.