TMC114 (darunavir) new drug applications submitted to US and European regulatory agencies

On 27 December, Tibotec Pharmaceuticals announced the submission of a New Drug Application to the United States Food and Drug Administration (FDA) for TMC114, an investigational protease inhibitor, being studied as a potential for treatment for people infected with HIV-1. A similar application to the European Agency for the Evaluation of Medicinal Products (EMEA) was submitted on 11 January 2006.

The submissions are 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. The POWER 1 data were presented at the International AIDS Society (IAS) conference in Rio de Janeiro in July 2005. The POWER 2 data were presented earlier this month at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington D.C.

TMC114, boosted with low-dose ritonavir, is currently in Phase III clinical trials in both treatment-experienced and treatment-naive HIV-1 infected patients. TMC114 is available through an expanded access program (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.