Labeling update for Tibotec Therapeutics' PREZISTA tablets approved

Jan 29 2010

Tibotec Therapeutics announced today that the U.S. Food and Drug Administration (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.

This indication is based on analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled Phase 3 trials of 48 weeks duration in antiretroviral treatment-naive and treatment-experienced patients and two controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.

In treatment-experienced adult patients, the following points should be considered when initiating therapy with PREZISTA/r:

• Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/r.
• The use of other active agents with PREZISTA/r is associated with a greater likelihood of treatment response.