Tibotec Pharmaceuticals has announced that the New Drug Application (NDA) for TMC114, an investigational HIV protease inhibitor, has been accepted for priority review by the United States Food and Drug Administration (FDA).
The Prescription Drug User Fee Act (PDUFA) user fee goal date for the NDA will be June 23, 2006.
The NDA is based on the efficacy and safety results of the 24 week analysis of two randomized, controlled studies, POWER 1 and POWER 2, and supportive open label safety data from POWER 3. 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 in December at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington D.C.
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 United States 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. For more about the program, healthcare professionals and people living with HIV/AIDS may obtain information by visiting www.tibotec.com or www.clinicaltrials.gov.
Pending US regulatory approval, Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will commercialize the product in the U.S. The trade name for the marketed product has not yet been determined.