TITUSVILLE, N.J., Oct. 21, 2011 /PRNewswire/ -- 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:
ARTEMIS 192-Week Study ResultsThe ARTEMIS study compared the efficacy and safety of PREZISTA/r 800/100 mg once daily (n=343) versus lopinavir/r 800/200 mg total daily dose (n=346) in treatment-naive adults with HIV-1. All patients received a fixed-dose combination of tenofovir and emtricitabine once daily. At 192 weeks, PREZISTA/r was shown to be non-inferior to lopinavir/r. This 192 week analysis showed that:
-- 70% of patients in the PREZISTA/r arm reached an undetectable viral load (less than 50 copies/m.) vs. 61% of patients in the lopinavir/r arm. Virologic failure was 12% in the PREZISTA/r arm and 15% in the lopinavir/r arm. Statistical superiority of PREZISTA/r over the lopinavir/r regimen was demonstrated in both the intent-to-treat (ITT) and on-protocol (OP) analysis.
-- The most common treatment-related adverse reactions (greater or equal to 5 percent) of moderate intensity (greater or equal to grade 2) among patients in the PREZISTA/r arm vs. lopinavir/r arm were: diarrhea (9 percent vs. 16 percent); headache (7 percent vs. 6 percent); abdominal pain (6 percent vs. 6 percent); and rash (6 percent vs. 7 percent).
About the ARTEMIS StudyARTEMIS (AntiRetroviral Therapy with TMC114 ExaMined In naive Subjects) is an international, randomized, controlled, open-label, non-inferiority, Phase 3 trial that compared the efficacy and safety of PREZISTA/r versus lopinavir/r in treatment-naive HIV-1-infected adult patients with viral load greater than 5,000 copies/mL.
The main objective of the study was to demonstrate non-inferiority of PREZISTA/r versus lopinavir/r in the proportion of patients achieving virologic response, defined as confirmed HIV RNA less than 50 copies/mL. Non-inferiority of PREZISTA/r vs. lopinavir/r was defined as a maximum allowable difference of 12 percent for virologic response, with a one-sided significance level of alpha equal to 0.025.
Important Safety Information PREZISTA does not cure HIV-1 infection or AIDS, and does not prevent passing HIV-1 to others.
This list of potential drug interactions is not complete.Warnings & Precautions
Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA/ritonavir therapy has not been established
Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of PREZISTA/ritonavir treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/ritonavir should prompt consideration of interruption or discontinuation of treatment
In clinical trials (N=3063), rash (all grades, generally mild to moderate, regardless of causality) occurred in 10.3% of patients receiving PREZISTA/ritonavir. Discontinuation due to rash was 0.5%
Use in Specific Populations
This is not a complete list of all adverse drug reactions reported with the use of PREZISTA/ritonavir.Please see accompanying full Prescribing Information for more details. Full prescribing information is also available at http://prezista.com/sites/default/files/pdf/us_package_insert.pdf
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Janssen Therapeutics At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in HIV and other infectious diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Headquartered in Titusville, New Jersey, Janssen Therapeutics, Division of Janssen Products, LP, is one of the Janssen Pharmaceutical Companies. Please visit JanssenTherapeutics.com for more information. Media Contact:
Pamela Van HoutenOffice: 609-730-7902Mobile: 908-295-7367Email: firstname.lastname@example.org Investor Contacts:
Louise Mehrotra, 732-524-6491Stan Panasewicz, 732-524-2524
|SOURCE Janssen Therapeutics, Division of Janssen Products, LP|
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