Tibotec Therapeutics announced today that the FDA has approved a labeling update for PREZISTA (darunavir) tablets to include 96-week data from the ARTEMIS and TITAN studies. Both ARTEMIS and TITAN evaluated the efficacy and safety of PREZISTA with ritonavir (r) vs. lopinavir/r in combination with other antiretrovirals (ARVs) for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients, respectively.
Based on the ARTEMIS results, the United States Department of Health & Human Services (DHHS) Guidelines for HIV recommended once daily PREZISTA/r, in combination with tenofovir/emtricitabine, as one of two preferred protease inhibitors (PIs) for patients starting therapy for the first time, in a December 2009 guidelines update.
“The addition of this information to the PREZISTA label demonstrates our commitment to providing information on the durability and safety profile of our medications over the long-term. In addition, Tibotec continues to invest in its long-standing research and development efforts to bring new options to people living with HIV,” said Glenn Mattes, President of Tibotec Therapeutics. PREZISTA was developed by Tibotec Pharmaceuticals and is marketed in the U.S. by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P. PREZISTA, co-administered with ritonavir (PREZISTA/r), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adults.