YARDLEY, PA, September 20, 2007 - 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 Friday, January 18, 2008.
sexta-feira, setembro 21, 2007
TMC125 para aprovação na FDA
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 anti-retroviral 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, Australia 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 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.
Etiquetas: TMC125
quarta-feira, julho 18, 2007
TMC 125 na FDA
New Drug Application for Investigational HIV Treatment TMC125 Submitted to U.S. Food and Drug Administration
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. Data from these studies were published in the
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sábado, abril 21, 2007
Notícias do programa de acesso alargado ao TMC125
Hospitais registados no EAP-TMC125 e respectivos doentes envolvidos:
-Hospital de Sto António dos Capuchos, Lisboa (7 doentes programados)
-Hospital de Santa Maria, Lisboa (2 doentes programados)
-Hospital Fernando da Fonseca, Amadora
-Hospital Pulido Valente, Lisboa
-Hospital Garcia de Orta, Almada
-Hospital de Cascais (2 doentes programados)
-Hospital de Santo António, Porto
Total: 11 doentes programados
