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news.Tibotec Pharmaceuticals has submitted a new drug application to the FDA for TMC125, an investigational non-nucleoside reverse transcriptase inhibitor, or NNRTI, being studied for use with other antiretroviral agents as a treatment for people infected with HIV- 1.
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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).
Tibotec says TMC125 is the first NNRTI to show antiviral activity in patients with documented NNRTI resistance. The company has received fast track designation for TMC125 from the FDA. This means the 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 US. 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.