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
YARDLEY, PA, 18th July 2007 - Tibotec Pharmaceuticals Ltd. today 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 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. Data from these studies were published in the
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.