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news.Ireland-based pharmaceutical R&D firm Tibotec Pharmaceuticals has announced that its new drug application for TMC114, an investigational HIV protease inhibitor, has been accepted for priority review by the FDA.
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The new drug application (NDA) for TMC114 is based on the efficacy and safety results from the 24-week analysis of two randomized, controlled studies, POWER 1 and POWER 2, and supportive open label safety data from POWER 3.
Phase III clinical trials of TMC114, boosted with low-dose ritonavir, are currently ongoing in both treatment-experienced and treatment-naive HIV-1 infected patients. TMC114 is available through an expanded access program (EAP) in the US for people living with HIV who need the compound to construct a viable treatment regimen and who are not eligible for other Tibotec clinical trials.
Pending US regulatory approval, Tibotec Therapeutics, a division of Ortho Biotech Products, will commercialize the product in the US. The trade name for the marketed product has not yet been determined.
Tibotec said that the Prescription Drug User Fee Act (PDUFA) user fee goal date for the NDA will be June 23, 2006.