Tibotec Therapeutics' INTELENCE granted FDA traditional approval

Nov 25 2009

The FDA granted traditional approval for INTELENCE® (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). 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 is currently marketed in the U.S. by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P.

"With its efficacy and tolerability demonstrated in 48-week studies, etravirine (INTELENCE) has become an important option for many treatment-experienced patients with resistance to NNRTIs or other antiretrovirals," said DUET clinical investigator Charles Hicks, MD, associate professor of medicine at Duke University's Division of Infectious Diseases in Durham, North Carolina.

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 who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents. This indication is based on Week 48 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.

The following points should be considered when initiating therapy with INTELENCE:

• Treatment history and, when available, resistance testing, should guide the use of INTELENCE.
• The use of other active antiretroviral agents with INTELENCE is associated with an increased likelihood of treatment response.
• In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs.
• The risks and benefits of INTELENCE have not been established in pediatric patients or in treatment-naive adult patients.