Tibotec Pharmaceuticals Ltd. submitted a new drug application to the US Food and Drug Administration for TMC114, an investigational protease inhibitor, being studied as a potential for treatment for people infected with HIV-1.
The submission is based on the efficacy and safety results of the 24 week dose-finding phase of two phase IIb randomised, controlled studies, Power 1 and Power 2, and supportive open label safety data from the Power 3 analyses.
TMC114, boosted with low-dose ritonavir, is currently in phase III clinical trials in both treatment-experienced and treatment-naïve HIV-1 infected patients. TMC114 is available through an expanded access programme (EAP) in the United States for people living with HIV who need the compound to construct a viable treatment regimen and who are not eligible for Tibotec clinical trials, states a company release.
Pending US regulatory approval, Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will commercialise the product in the US regulatory submissions for TMC114 in other countries are expected in coming months.
Tibotec Pharmaceuticals Ltd. is a pharmaceutical research and development company. That discovers and develops innovative HIV/AIDS drugs and superior anti-infectives for diseases of high unmet medical need.