Tibotec Pharmaceuticals Ltd. has announced the submission of a New Drug Application to the U.S. Food and Drug Administration (FDA) for TMC125 (etravirine), an investigational non- nucleoside reverse transcriptase inhibitor (NNRTI), being studied for use with other antiretroviral (ARV) agents as a treatment for people infected with HIV- 1.
The submission is based on the 24-week efficacy and safety results of two Phase III randomized, placebo-controlled studies, known as DUET-1 and DUET-2, which studied the use of TMC125 in combination with other antiretroviral agents in adult treatment-experienced HIV-1 patients with documented resistance to NNRTIs and protease inhibitors (PIs). Data from these studies were published in the July 7, 2007 issue of The Lancet and will be shown at a late-breaker presentation at the 2007 International AIDS Society (IAS) conference in Australia on July 25th.
TMC125 is the first NNRTI to show antiviral activity in patients with documented NNRTI resistance. Tibotec has received fast track designation for TMC125 from the FDA. Under fast track designation in the FDA Modernization Act of 1997, FDA may expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and demonstrates the potential to address an unmet medical need for such a condition.
The expanded access program (EAP) for TMC125 is now open in a number of European countries, Canada and the United States. TMC125 is available to HIV-1 infected adults, at least 18 years old, who have limited treatment options either due to virological failure or intolerance to multiple ARV regimens. Patients must be three-class experienced, having received licensed treatment from each of the three major oral classes of anti-HIV drugs (NRTIs, NNRTIs, and PIs), unable to use currently approved NNRTIs due to resistance and/or intolerance and have received at least two PI-based regimens.
Pending US regulatory approval, Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will commercialize the product in the U.S. The trade name for the marketed product has not yet been determined. Regulatory submissions for TMC125 in other countries are expected in the coming months.