Navigation Links
FDA Approves Label Update for PREZISTA® to Include 192-Week Data in HIV-1-Infected Adult Patients Starting Treatment
Date:10/21/2011

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:

  • 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.

  • ARTEMIS 192-Week Study
    '/>"/>

    SOURCE Janssen Therapeutics, Division of Janssen Products, LP
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6

    Related medicine technology :

    1. FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body
    2. FDA Approves Combination Therapy Juvisync
    3. FDA Approves Cialis to Treat Benign Prostatic Hyperplasia
    4. FDA Approves Remicade to Treat Ulcerative Colitis in Children Older Than 6 Years
    5. FDA Approves Soliris for Rare Pediatric Blood Disorder
    6. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
    7. FDA Approves Xalkori with Companion Diagnostic for a Type of Late-stage Lung Cancer
    8. FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
    9. FDA Approves Adcetris to Treat Two Types of Lymphoma
    10. FDA Approves the First Specific Treatment for Scorpion Stings
    11. Cardinal Health Board of Directors Approves Cash Dividend, Elects David P. King as Director
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:1/23/2015)... , Jan. 23, 2015  MedScope ( www.medscope.org ), the ... for a 2015 Connected World magazine Connected ... System (mPERS), that can be used anywhere, anytime. The ... In nominating MedScope, Landon Garner ...
    (Date:1/23/2015)... Rose, baseball,s all-time hits leader, is the new spokesperson for ... Pharma has announced. "Pete,s a Hall of Famer ... on board with Myoflex," said Ducere Pharma Chief Executive Officer ... is known across all generations. The passion and intensity that ...
    (Date:1/23/2015)... , Jan. 23, 2015  Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT), ... I trial of Lixte,s lead compound, LB‑100, is being conducted, ... John S. Kovach , M.D., the founder and President ... be completed at a single site. Accrual of patients, however, ...
    Breaking Medicine Technology:MedScope Nominated by RacoWireless for Prestigious 2015 Connected World Magazine Connected World Award 2Pete Rose bets on Myoflex to relieve aches and pains 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 3
    ... Denali Concrete Management Inc. (OTCBB: DCMG) announced today ... acquisition of Denali by Can-Fite BioPharma Ltd. (TASE: CFBI) ... outstanding shares of EyeFite Ltd., a private company incorporated ... exclusive license over CF101 for ophthalmic indications. Concurrently, Denali ...
    ... 22, 2011 Par Pharmaceutical Companies, Inc. (NYSE: ... approved the promotions of Thomas J. Haughey to the role ... Chief Operating Officer of the Company and its subsidiaries, effective ... LePore who will retain his title of Chairman of the ...
    Cached Medicine Technology:Denali Concrete Management Inc. Announces its Acquisition of CF101 for Ophthalmic Indications and the Completion of Above $6 Million Private Placement at $1.144 Per Share 2Denali Concrete Management Inc. Announces its Acquisition of CF101 for Ophthalmic Indications and the Completion of Above $6 Million Private Placement at $1.144 Per Share 3Par Pharmaceutical Companies Promotes Thomas J. Haughey to President and Paul V. Campanelli to Chief Operating Officer 2
    (Date:1/22/2015)... AngelWeddingDress, the premier women’s dress supplier, has ... View website of AngelWeddingDress.com to find more ... dresses online for a bridal party. AngelWeddingDress offers a ... them. Its maternity wedding dresses are specially designed for ...
    (Date:1/22/2015)... Autocarinsurancebest.com has released a new blog post explaining the ... . , Auto insurance quotes help many drivers find ... necessary to call an agent or visit an agency for ... single website: http://autocarinsurancebest.com/ . , Every business who relies ...
    (Date:1/22/2015)... 2015 Yesterday, Senator Holly Mitchell ... Kristin Olsen (R-Modesto) were honored by the California ... biotechnology, biomedical science, medical device and pharmaceutical innovation ... the “2014 Life Sciences Champion” award from CHI ...
    (Date:1/22/2015)... January 22, 2015 EBSCO Information Services ... are expanding their relationship in an effort to further promote ... world. While EBSCO has long made AMA journals available via ... agent for The JAMA Network. , Long known ...
    (Date:1/22/2015)... Step into a macabre world where ... of Virginia. Wicked Plants, the Museum’s latest featured exhibition, ... poisonous, carnivorous and diabolical plants inside of a dilapidated, ... the biochemical, physical and neurological processes between botanicals and ...
    Breaking Medicine News(10 mins):Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:EBSCO Expands Partnership with the American Medical Association 2Health News:EBSCO Expands Partnership with the American Medical Association 3Health News:EBSCO Expands Partnership with the American Medical Association 4Health News:Wicked Plants are taking over the Science Museum of Virginia 2
    ... patients with coronary artery disease were almost three times ... interventional treatment to arterial plaque than their White European ... IJCP, the International Journal of Clinical Practice . ... emergency and require urgent treatment. Researchers carried out ...
    ... in sexual activity, the more likely they are to ... to new research presented in Boston at The Gerontological ... This finding is based on the 2004� General Social ... representative sample of non-institutionalized English and Spanish-speaking person 18 ...
    ... FRIDAY, Nov. 18 (HealthDay News) -- New research suggests that ... communicating via email or instant messages rather than when they ... What,s new is that we lie even more online," said ... at the University of Massachusetts-Amherst. In the study, the ...
    ... - IBM,s Watson computing system broke new ground earlier this ... Jeopardy! game show. Now, The Scripps Research Institute is hoping ... health with part of the prize money from that tournament: ... the public,s help. To that end, Scripps Research ...
    ... at the University of California, San Diego School of Medicine ... colleagues in Boston and South Korea, say they have identified ... of glioblastoma (GBM), the most common type of malignant brain ... online edition of the journal Cancer Research . ...
    ... 2011 - The Canadian Diabetes Association is pleased to ... Elsevier to publish the Canadian Journal of Diabetes ... CJD is Canada,s only diabetes-oriented, peer-reviewed, interdisciplinary ... the sharing and enhancement of knowledge to advance the ...
    Cached Medicine News:Health News:South Asian patients require 3 times as much repeat angioplasty as white Europeans 2Health News:South Asian patients require 3 times as much repeat angioplasty as white Europeans 3Health News:Study finds sex a significant predictor of happiness among married seniors 2Health News:People May Lie More Often in Emails, Instant Messages 2Health News:Jeopardy! winnings spur IBM and Scripps Research Institute collaboration to fight against malaria 2Health News:Jeopardy! winnings spur IBM and Scripps Research Institute collaboration to fight against malaria 3Health News:Old drugs find new target for treating brain tumor 2Health News:Old drugs find new target for treating brain tumor 3
    Used for dilation of a tract to the kidney for removal of stones. Supplied sterile in peel-open packages. Intended for one-time use....
    ... supplied on Smart Cards. Insert the card and ... and turns itself off after the programmed time. ... duration of treatments. Simply provide your patient with ... their progress on the next visit.,The initial set ...
    ... painfree therapy stimulates the spincter and ... contractions and relaxation. By use of ... surgical operations (bladder liftings) may be ... can improve unsatisfying results. DETRUSAM intravesical ...
    ... ELPHA 4 Conti is a battery operated ... treatment of conditions described below. ELPHA 4 Conti ... In STRESS- and faecal incontinence ELPHA 4 Conti ... that the user can feel which muscles need ...
    Medicine Products: