The FDA has granted traditional approval for Tibotec Therapeutics’ Intelence (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). Intelence is currently marketed in the US by Tibotec, a division of Centocor Ortho Biotech Products.
The company claims that Intelence is the only NNRTI, specifically indicated for use in treatment-experienced adults, who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents.
The traditional approval is based on 48-week data from two Phase 3 studies known as Duet-1 and Duet-2.
Intelence received accelerated approval by the FDA in January 2008 and has been approved in more than 50 countries since then. In January 2009, an application for traditional approval was submitted to the FDA, which included 48-week data from Duet-1 and Duet-2.
Intelence, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.
This indication is based on 48 week analysis from two randomised, double-blind, placebo-controlled trials of Intelence.