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Application for Etravirine Submitted for FDA Review
INTELENCE received accelerated approval in January 2008. As part of the post-marketing commitment, Tibotec is required to submit 48-week data from the DUET studies to the FDA in order for it to consider traditional approval for INTELENCE.
INTELENCE, in combination with other antiretroviral agents, is currently indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a NNRTI and other antiretroviral (ARV) agents.
This indication is based on Week 24 analyses from two randomized, double-blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.