Navigation Links
FDA Approves KRYSTEXXA™ (pegloticase) for the Treatment of Chronic Gout in Adult Patients Refractory to Conventional Therapy
Date:9/14/2010

EAST BRUNSWICK, N.J., Sept. 14 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that the U.S. Food and Drug Administration (FDA) has approved KRYSTEXXA™ (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.  Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

"KRYSTEXXA is the first-ever and only treatment approved by the FDA for adult patients who suffer with chronic gout that is refractory to conventional therapy," said Paul Hamelin R.Ph., President of Savient Pharmaceuticals.  "The clinical data have demonstrated that many patients treated with KRYSTEXXA 8 mg administered every two weeks can experience within six months of treatment significant positive clinical improvement reversing the course of this severe, crippling and debilitating disease. A statistically significant proportion of patients in our pivotal clinical trials achieved a lowering of their serum uric acid level to a mean of 0.7 mg/dL and achieved a complete response for the resolution of tophi within the first six months of therapy. We believe that the approval of KRYSTEXXA is a significant step towards realizing our mission of transforming the lives of the patients in the U.S. suffering with chronic gout refractory to conventional therapy, as many of them finally have a treatment that gives them hope of reversing this severely debilitating disease."

Savient expects KRYSTEXXA to be available by prescription in the U.S. later this year a
'/>"/>

SOURCE Savient Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related biology technology :

1. European Union Approves Maize with Herculex® I/Herculex® RW and Herculex® RW/ Herculex® I/Roundup Ready® Corn 2 Trait Stacks for Import, Food, Feed & Processing
2. FDA Approves First-of-Its-Kind HIV Test Which Can Detect HIV Days Earlier Than Current U.S. Tests
3. Aeterna Zentaris: FDA Approves Investigational New Drug (IND) Application for Doxorubicin Targeted Conjugate Compound, AEZS-108, in Bladder Cancer
4. FDA Approves Five-Day Dosing Regimen for Dacogen(R) (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)
5. European Union Approves Corn Stack with Herculex RW and Roundup Ready 2 Traits for Food, Feed, Import and Processing
6. EU Committee Approves New Food Applications for Marteks lifesDHA(TM)
7. EU Committee Approves New Food Applications for Martek's life'sDHA™
8. Photos: FDA Approves 12-Month Labeling Update for EVOLENCE(R) Collagen-Based Facial Filler
9. FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD
10. FDA Approves Boston Scientifics Next-Generation TAXUS(R) Liberte(R) Atom(TM) Stent System
11. Arpida Annual General Meeting of Shareholders Approves All Board Proposals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... PETERSBURG, Russia , July 10, 2014 ... Russian Federation Dmitry Medvedev , presented ... biopharmaceutical company BIOCAD . The Company is developing ... scope of MabNext project BIOCAD develops a number of ... cancer and autoimmune diseases. The ceremony took place at ...
(Date:7/10/2014)... 2014   Ceres, Inc . (Nasdaq: ... today financial results for the three months ended May ... Ceres reported that the company and its ... growing season in Brazil, which concluded in June, despite ... evaluation areas for part of the growing season. Yields ...
(Date:7/10/2014)... the journal PNAS (Proceedings of the National Academy ... and sleep deprivation have a significant effect on our ... the best time of day to test for diseases ... medicines effectively. , Researchers from the University of Surrey ... links between sleep deprivation, body clock disruption and metabolism, ...
(Date:7/10/2014)... forever. Nanophysics makes sure of that. Mechanics researchers at Linkping ... Physical Review E . Knowledge that can be of ... be able to sit still forever, and walk around upside ... soon be able to buy smart new fasteners that hold ... is, sooner or later the grip is lost, no matter ...
Breaking Biology Technology:Dmitry Medvedev Presented BIOCAD the First National "Industry" Award 2Ceres Announces Fiscal Third Quarter 2014 Financial Results 2Ceres Announces Fiscal Third Quarter 2014 Financial Results 3Ceres Announces Fiscal Third Quarter 2014 Financial Results 4Ceres Announces Fiscal Third Quarter 2014 Financial Results 5Ceres Announces Fiscal Third Quarter 2014 Financial Results 6Ceres Announces Fiscal Third Quarter 2014 Financial Results 7Ceres Announces Fiscal Third Quarter 2014 Financial Results 8Ceres Announces Fiscal Third Quarter 2014 Financial Results 9Time of day crucial to accurately test for diseases, new research finds 2Even geckos can lose their grip 2
... drug discovery and development company eMetagen Corp . ... Marquette University Golden Angels Network , the angel investors ... Golden Angels investment, along with two grants received last ... the National Institutes of Health and a $150,000 Technology ...
... in any foreign land now requires a quick custom check. ... true nationality? What's this nation doing on the global scene ... Do I really like this nation? , ,It's no secret ... savvy than they were a decade ago. They clearly support ...
... - Ann Stunden, director of the Division of ... received a 2005 award for information technology leadership from ... honored Stunden for "strong and ground-breaking leadership in the ... 37 years ago." , ,A co-founder and executive ...
Cached Biology Technology:eMetagen gets $535,000 from MU angel investors 2Why are brands culturally profiled? 2Why are brands culturally profiled? 3
(Date:7/11/2014)... Researchers from Salk Institute for Biological Studies, BGI, ... the safety and reliability of the existing targeted ... method, TALEN-HDAdV, which could significantly increased gene-correction efficiency ... study published online in Cell Stell Cell ... cell-based gene therapy. , The combination of stem ...
(Date:7/11/2014)... 11, 2014 The increased risk of kidney injury ... resuscitation fluids reflects the mass of HES molecules, according ... official journal of the International Anesthesia Research Society (IARS). ... harmful effect of HES on cultured human renal proximal ... Christian Wunder and colleagues of University Hospital Wrzburg, Austria. ...
(Date:7/11/2014)... , July 11, 2014 Research ... "International Biometrics Technology Market - Industry Analysis Size ... to their offering. http://photos.prnewswire.com/prnh/20130307/600769 ... and crimes has created a need for high level ... used for personnel authentication such as username and passwords, ...
Breaking Biology News(10 mins):A new genome editing method brings the possibility of gene therapies closer to reality 2In lab studies, hydroxyethyl starch has direct harmful effects on kidney cells 2International Biometrics Technology Market - Industry Analysis Size Share Growth Trends and Forecast to 2019 2
... When students using the Ask a Biologist Web site ask ... actually accessing the combined knowledge of more than 150 volunteer ... "That,s why Dr. Biology is so amazing," says Charles Kazilek, ... on the planet." Kazilek,s site, which attracts 3,000-4,000 visitors ...
... for the Advancement of Science has chosen Arizona State ... science education, to receive the Science Prize ... The prize, established to "encourage innovation and excellence in ... resources by students, teachers, and the public," recognizes the ...
... fish species in the ocean, but the majestic gliding ... astonishing feat of mathematics and energy conservation. In new ... Functional Ecology marine scientists reveal how these ... buoyancy and stay afloat. For most animals movement ...
Cached Biology News:Science selects 'Ask a Biologist' website to win SPORE award 2Science selects 'Ask a Biologist' website to win SPORE award 3Science selects 'Ask a Biologist' website to win SPORE award 4ASU’s Ask A Biologist website wins prestigious SPORE prize 2ASU’s Ask A Biologist website wins prestigious SPORE prize 3Whale sharks do the math to avoid that sinking feeling 2
Anti-TNKS2 Polyclonal AntibodyOther Sub-Family: not assigned-Other Applications: ELISA, Western Blot...
Rabbit Anti-Human Janus Kinase 2 (JAK2 Polyclonal Antibody Family: Protein Kinase Sub-Family: TYK2/JAK Applications: ELISA, Western Blot...
Goat polyclonal to Lipocalin 2...
Human GCP-2 is a member of the CXC family of chemokines. It also promotes neutrophil chemotaxis and deganulation. GF063 is an 8.0 kDa protein containing 73 amino acid residues....
Biology Products: