FDA Approves New Dosage Strength for INTELENCE®

On January 3, 2011, the U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

The recommended oral dose of INTELENCE tablets is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal. The new 200 mg product formulation is expected to launch in the U.S. later this month, and the 100 mg tablet will remain available. Patients who are unable to swallow INTELENCE tablets whole may disperse the tablets in a glass of water.

The FDA granted accelerated approval to INTELENCE in January 2008, and it has since been approved in more than 65 countries. INTELENCE received traditional FDA approval in November 2009, based on 48-week data from the DUET-1 and DUET-2 studies, and is currently marketed in the U.S. by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P.


INTELENCE Indication

INTELENCE, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in ARV treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other 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 ARV (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 ARV 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-naïve adult patients.

This new 200mg formulation of INTELENCE will make dosing easier for patients taking it and will help improve adherence. Instead of taking 4 INTELENCE Tablets each day patients will take 2 of the 200mg tablets each day- 1 every 12 hours. The company is expected to launch the new 200g formulation later this month and will then be available pharmacies