FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatm...( - The Prescription Drug User Fee Ac...),Health

- The Prescription Drug User Fee Act (PDUFA) user fee goal date will be

January 18, 2008 -

YARDLEY, Pa., Sept. 20 /PRNewswire/ -- Tibotec Pharmaceuticals Ltd. today announced that the New Drug Application (NDA) for TMC125 (etravirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), has been accepted for priority review by the United States Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) user fee goal date for the NDA for TMC125, the date by which the FDA must announce its decision regarding the application, will be January 18, 2008.

The NDA for TMC125, the first NNRTI to show antiviral activity in patients with documented NNRTI resistance, is based on the 24-week efficacy and safety results of two ongoing Phase III randomized, double-blinded, placebo- controlled studies, known as DUET-1 and DUET-2. The DUET studies examined the use of TMC125 in combination with other antiretroviral agents in adult treatment-experienced HIV-1 patients. The safety and efficacy of TMC125 in combination with other antiretroviral agents has not been established.

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 ARV regimens. Patients must be three-class experienced, having received 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 U.S. 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 det
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