Prezista
Generic name: darunavir
Treatment for: HIV Infection
New Drug Application for Investigational HIV Protease Inhibitor TMC114 Submitted to U.S. Food & Drug Administration
HIV/AIDS Compound Marks First Regulatory Submission by Tibotec Pharmaceuticals Ltd.
CO CORK, Ireland, December 27, 2005 -- Tibotec Pharmaceuticals Ltd. today 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.
The submission is based on the efficacy and safety results of the 24 week dose-finding phase of two Phase IIb randomized, 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-naïve 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.
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.
Regulatory submissions for TMC114 in other countries are expected in coming months.
Posted: December 2005
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Prezista (darunavir) FDA Approval History
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