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Tibotec Pharmaceuticals Ltd. has announced that the Food and Drug Administration (FDA) has accepted their new drug application for TMC125 (etravirine). The Prescription Drug Use Fee Act user fee goal date-the date by which the FDA must announce its decision-is January 18, 2008. Pending FDA approval, Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will market the product in the United States. The brand name has not yet been determined.

TMC125 is an investigational non-nucleoside reverse transcriptase inhibitor (also known as an "NNRTI" or "non-nuke.") It is in the same category of drugs as Sustiva (efavirenz) and Viramune (nevirapine).

The reason the HIV community is excited about this new drug is because TMC125 is a "next-generation" NNRTI. It is the first NNRTI to work in patients with documented resistance to other NNRTIs and protease inhibitors.

The new drug application for TMC125 is backed up by data from two ongoing Phase III trials known as DUET-1 and DUET-2. Data from these two trials was published in the July 7, 2007 issue of The Lancet. It showed that significantly more patients with documented resistance to NNRTIs and PIs achieved a confirmed undetectable level (below 50 copies) with TMC125 and a background regimen than with a placebo and background regimen at 24 weeks.

"The NNRTI class has been one of the cornerstones of antiretroviral therapy for more than a decade. However, NNRTI resistance limits the use of this class in treatment-experienced patients," said Tony Mills, MD, HIV specialist in private practice, Los Angeles, and Assistant Professor of Clinical Medicine, UCLA. "The results that we saw in DUET-1 and 2 in patients with documented NNRTI resistance are very exciting and suggest that in the future, we may have the ability to sequence NNRTIs in HIV treatment."

TMC125 is currently available through an expanded access program (EAP) in the United States, as well as a number of European countries and Canada. The EAP provides access to TMC125 to HIV-1 infected adults, at least 18 years old, who have limited treatment options either due to virological failure or intolerance to multiple anti-retroviral regimens. Patients must be three-class experienced, having received treatment from each of the three major classes of HIV medications (NRTIs, NNRTIs, and PIs,) unable to use any currently approved NNRTIs due to resistance and/or intolerance, and have received at least two PI-based regimens.

For more information on the EAP program, ask your doctor to call 1-866-889-2074 or e-mail TMC125EAP@i3research.com.

Copyright 2008, Positive Health Publications, Inc.

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