Janssen announces FDA label update approval for PREZISTA HIV tablets

Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for PREZISTA® (darunavir) tablets to include 192-week data from the ARTEMIS study.  ARTEMIS 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 patients.

"Since its launch in 2006, PREZISTA has become one of the most prescribed antiretroviral agents in the protease inhibitor class.  Having data showing the efficacy, safety, and tolerability of PREZISTA over 192 weeks should give added confidence to healthcare providers who are considering PREZISTA as an option for their patients who are starting treatment for the first time," said Vanessa Broadhurst, President, Janssen Therapeutics.

PREZISTA was developed by Tibotec Pharmaceuticals and is marketed in the U.S. by Janssen Therapeutics. PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

This indication is based on analyses of plasma HIV-1 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.