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news.Janssen International's Edurant (rilpivirine) has received approval by the European Commission (EC), as a once daily treatment for HIV-1 infection in antiretroviral agent (ARV) treatment-naive adult patients.
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Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI), which blocks reverse transcriptase, a key enzyme that is used by the HIV virus to replicate.
The marketing authorisation of rilpivirine is backed by two randomised, double blind, active controlled, global Phase 3 clinical trials, ECHO and THRIVE .
The trials demonstrated the efficacy, safety and tolerability of rilpivirine compared to efavirenz in more than 1,350 treatment-naïve HIV-1 adult patients.
Rilpivirine was approved by the US Food and Drug Administration (FDA) in May 2011 and by the Canadian health authorities (Health Canada) in July 2011.