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:4/1/2015)... 2015 Emerson Ecologics is excited to announce ... Better Medicine . The conference will provide integrative healthcare ... thriving and fulfilling practice. Scheduled for ... and Spa, the conference will be a one-of-a-kind, "get ... key projects and leave with an action plan in ...
(Date:4/1/2015)... 1, 2015  VLP Therapeutics, LLC. ("VLP"), a ... research and development of therapeutic and preventative vaccines and ... proprietary vaccine technology, today announced that it has entered into ... at Nagasaki University in ... research and development of dengue vaccine candidates. ...
(Date:4/1/2015)... BALTIMORE , Apr. 1, 2015 Goldman ... on the small cap and microcap sectors, announced today ... Biotech, Inc. (OTCQB – PMCB), a publicly traded clinical ... for cancer and diabetes. To view the sponsored research ... it in its entirety, please visit www.GoldmanResearch.com .  ...
(Date:4/1/2015)... -- EMD Serono, the U.S. biopharmaceuticals subsidiary of Merck KGaA, ... appointment of Frederick E. Munschauer to Vice ... capacity, he will lead the medical affairs activities for ... Rebif ® (interferon beta-1a) as well as the ... Munschauer joins EMD Serono from Biogen, bringing more than ...
Breaking Biology Technology:Emerson Ecologics Announces First Annual Conference for Integrative Healthcare Practitioners 2Emerson Ecologics Announces First Annual Conference for Integrative Healthcare Practitioners 3VLP Therapeutics Enters Collaboration with Institute of Tropical Medicine, Nagasaki University 2VLP Therapeutics Enters Collaboration with Institute of Tropical Medicine, Nagasaki University 3Flurry of Biotech Mergers and Acquisitions Bodes Well for PharmaCyte Biotech 2Flurry of Biotech Mergers and Acquisitions Bodes Well for PharmaCyte Biotech 3Flurry of Biotech Mergers and Acquisitions Bodes Well for PharmaCyte Biotech 4EMD Serono Appoints Frederick E. Munschauer M.D., FAAN to Vice President of Medical Affairs, Neurology and Immunology 2EMD Serono Appoints Frederick E. Munschauer M.D., FAAN to Vice President of Medical Affairs, Neurology and Immunology 3EMD Serono Appoints Frederick E. Munschauer M.D., FAAN to Vice President of Medical Affairs, Neurology and Immunology 4EMD Serono Appoints Frederick E. Munschauer M.D., FAAN to Vice President of Medical Affairs, Neurology and Immunology 5
... MEDFORD/SOMERVILLE, Mass. -- Promising research on superconducting materials, near ... Tufts University,s School of Engineering early career awards from ... The awards are among the most prestigious honors given ... at the early stages of their careers, when many ...
... March 23 The Superior Court of Pennsylvania has reinstated an appeal filed by ... been dismissed by an order from the same court on February 18, 2010 . The Superior Court also ... ... , ...
... - and authorities on the track of illicit alcohol ... hand. Measurement experts have unveiled a portable device to ... almost anywhere. Published in the open access Chemistry ... is just as accurate, and more sophisticated, than widely ...
Cached Biology Technology:3 Tufts engineering faculty earn prestigious national awards for promising research 23 Tufts engineering faculty earn prestigious national awards for promising research 3UPDATE: Appeal of Lawsuit by Former Chief Executive Officer- Reinstated; and Sanctions Order Vacated 2How strong is your booze? 2
(Date:3/18/2015)... March 18, 2015 As mobile payments ... revolutionary smart wallets and apps continue to be introduced into ... in the mobile payment industry in focus today are:  NXT-ID, ... (NYSE: BABA ), Apple Inc. (NASDAQ: ... Facebook Inc. (NASDAQ: FB ) NXT-ID, ...
(Date:3/16/2015)... 16, 2015 Between 16 ... present groundbreaking innovations in biometric identification at the ... .      (Photo: http://photos.prnewswire.com/prnh/20150316/735333 ... is well at the forefront: the company,s all ... in Germany . BiometricGate is ...
(Date:3/12/2015)... March 12, 2015 WHEN:Tuesday, March 17, 2015 ... http://bit.ly/1G7Os0L . SPEAKERS: , Frost & Sullivan ... http://photos.prnewswire.com/prnh/20150311/181111 Biometric companies must ... in several different markets and industries. This is ... an uptrend. Join Frost & ...
Breaking Biology News(10 mins):Revolutionary Smart Wallet & Mobile Payment Choices Change the Game for Consumers - Company Begins Shipping Newest Digital Wallet to Customers 2Revolutionary Smart Wallet & Mobile Payment Choices Change the Game for Consumers - Company Begins Shipping Newest Digital Wallet to Customers 3Revolutionary Smart Wallet & Mobile Payment Choices Change the Game for Consumers - Company Begins Shipping Newest Digital Wallet to Customers 4Revolutionary Smart Wallet & Mobile Payment Choices Change the Game for Consumers - Company Begins Shipping Newest Digital Wallet to Customers 5Revolutionary Smart Wallet & Mobile Payment Choices Change the Game for Consumers - Company Begins Shipping Newest Digital Wallet to Customers 6DERMALOG Presents its Latest Biometric Innovations at the Hannover CeBIT Exhibition, 16 - 20 March 2015 2DERMALOG Presents its Latest Biometric Innovations at the Hannover CeBIT Exhibition, 16 - 20 March 2015 3Biometrics Key to Future Growth in Healthcare, Retail and Financial Markets 2Biometrics Key to Future Growth in Healthcare, Retail and Financial Markets 3
... RIVERSIDE, Calif. ( www.ucr.edu ) -- A team led ... Bourns College of Engineering has made a discovery in ... from kill viruses to increase storage capacity of DVDs. ... data processing, information storage and biology. Their applications have ...
... 19th conference of the International Society for Sexually Transmitted ... in Quebec City, Canada. The world,s foremost conference ... 1,200 scientists from every continent to discuss the most ... and treatment; emerging threats in bacterial STDs; major intervention ...
... Spanish . The last of seven cotton ... a major 4-year cotton gin dust sampling project draws to ... project to intensively sample emissions from seven cotton gins across ... Research Service (ARS) Cotton Production and Processing Research Unit in ...
Cached Biology News:New laser technology could kill viruses and improve DVDs 2ARS and cooperators study cotton gin dust emissions 2
Newborn Bovine Serum Heat-Inactivated...
Performance, mycoplasma, virus, and endotoxin tested...
Bethyl Laboratories Ready-To-Use IHC Bluing Reagent is used following IHC hematoxylin counterstaining with immunohistochemical procedures. Shelf-Life: 1 year from date of receipt...
... BlueJuice Gel Loading Buffer ... loading and tracking of ... or native polyacrylamide gels. ... higher density sucrose which ...
Biology Products: