Navigation Links
Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients
Date:1/28/2009

EAST BRUNSWICK, N.J., Jan. 28 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that its biologics license application (BLA) for pegloticase for treatment-failure gout will be reviewed by the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) on March 5, 2009 as required for a drug of a new therapeutic class.

Savient submitted its BLA to the FDA on October 31, 2008 seeking approval to market pegloticase in the United States. On December 29, 2008, the FDA accepted the BLA filing for review and granted priority review. A priority review is an FDA designation that is assigned to products that if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under priority review, the target date for an FDA decision on the pegloticase BLA is April 30, 2009.

Savient's filing includes data from both the six-month placebo-controlled Phase 3 pivotal trials, as well as data from the open label extension (OLE) study. The two replicate six-month Phase 3 clinical trials for pegloticase were performed under the auspices of a Special Protocol Assessment (SPA) (2006). Pegloticase was granted orphan drug designation by the FDA in 2001.

ABOUT SAVIENT PHARMACEUTICALS, INC.

Savient Pharmaceuticals, Inc. is a biopharmaceutical company engaged in developing and distributing pharmaceutical products that target unmet medical needs in both niche and broader markets. The Company's product development candidate, pegloticase for treatment-failure gout, has reported positive Phase 1, 2 and 3 clinical data. Patient dosing in the Phase 3 clinical studies began in June 2006; patient enrollment was completed in March 2007; and t
'/>"/>

SOURCE Savient Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
8. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
9. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
10. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/1/2015)... Sept. 1, 2015  AccuTec Blades, Inc. today announced ... Blades division.  EPC announced in May 2015 its intent ... Verona, Virginia and Obregon, Mexico ... sale process. Rick Gagliano , ... Blades said, "Our new name, AccuTec Blades, reflects the ...
(Date:9/1/2015)... --NOWDiagnostics Inc., based in Springdale, Ark. , ... Canada , a move that brings the company ... have greater access to information concerning their health. ... blood-based rapid tests that allow health care providers to ... ailments and diseases. ZBx Corporation, a Toronto ...
(Date:9/1/2015)... DALLAS , Sept. 1, 2015 UT ... and distinguished faculty members joined U.S. Representatives ... in a roundtable discussion on the 21 st ... biomedical research currently being considered by the ... faculty – including National Academy of Sciences members, department ...
Breaking Medicine Technology:AccuTec Blades, Inc. Announces Acquisition of Industrial Blades Division from Edgewell Personal Care Company 2NOWDiagnostics Inc. Acquires Canada's ZBx Corporation 2NOWDiagnostics Inc. Acquires Canada's ZBx Corporation 3U.S. Rep. Michael C. Burgess, M.D., hosts roundtable at UT Southwestern to discuss pivotal 21st Century Cures Act and future of biomedical science 2U.S. Rep. Michael C. Burgess, M.D., hosts roundtable at UT Southwestern to discuss pivotal 21st Century Cures Act and future of biomedical science 3U.S. Rep. Michael C. Burgess, M.D., hosts roundtable at UT Southwestern to discuss pivotal 21st Century Cures Act and future of biomedical science 4U.S. Rep. Michael C. Burgess, M.D., hosts roundtable at UT Southwestern to discuss pivotal 21st Century Cures Act and future of biomedical science 5
... Conn., May 15, 2012 /PRNewswire-iReach/ -- Global ... important Cambridge Healthtech Institute conferences: IMVACS – ... August 13 – 15, Cambridge, MA - The ... under one heading: the Seventh Annual Novel Vaccines, Design ...
... Labs, Inc. (OTCQB/OTCBB: GOVX), a biotechnology company that creates, ... results for the three months ended March 31, 2012 ... delighted with recent developments that have strengthened and advanced ... David Dodd. "Our Phase 1/2 therapeutic vaccine trial continues ...
Cached Medicine Technology:Attendees Save up to $350 on CHI Conferences This Summer by Registering Through Global Information 2GeoVax Labs Reports 2012 First Quarter Financial Results 2GeoVax Labs Reports 2012 First Quarter Financial Results 3GeoVax Labs Reports 2012 First Quarter Financial Results 4GeoVax Labs Reports 2012 First Quarter Financial Results 5GeoVax Labs Reports 2012 First Quarter Financial Results 6
(Date:9/1/2015)... (PRWEB) , ... September 01, 2015 , ... From Aug. ... children and teenagers, from ages 6-18. Calvary’s Camp Compass® has taken place at Kingsborough ... included 65 adult counselors, some of whom work for Calvary, and two junior counselors ...
(Date:9/1/2015)... Jersey (PRWEB) , ... September 01, 2015 , ... Horizon ... of the 50 Best Companies for Latinas in the LATINA Style 50 Report that ... States. , For 2015, Horizon BCBSNJ climbs from number 24 to ...
(Date:9/1/2015)... ... September 01, 2015 , ... ... prevent different malignancies. Some options for cancer treatment are available belonging to ... distinctive approach is necessary for effective treatment. Several molecules have been discovered ...
(Date:9/1/2015)... ... September 01, 2015 , ... As part ... and Blue Shield of Minnesota (Blue Cross) has announced Doctor On Demand as ... San Francisco, Doctor On Demand provides immediate access to Board Certified physicians or ...
(Date:9/1/2015)... ... September 01, 2015 , ... ... negative pressure inside a wound to remove exudates, fluid, and infectious materials to ... portable devices, stand-alone devices, disposable devices, and canisters, etc.) is projected to expand ...
Breaking Medicine News(10 mins):Health News:Calvary Hospital Hosts 18th Annual Bereavement Camp 2Health News:Calvary Hospital Hosts 18th Annual Bereavement Camp 3Health News:Horizon Blue Cross Blue Shield of New Jersey Named One of the 50 Best Companies for Latinas by Latina Style Magazine 2Health News:Horizon Blue Cross Blue Shield of New Jersey Named One of the 50 Best Companies for Latinas by Latina Style Magazine 3Health News:CD Antigen Cancer Market and Pipeline Landscape Examined in Comprehensive Kuick Research Report Published at MarketPublishers.com 2Health News:CD Antigen Cancer Market and Pipeline Landscape Examined in Comprehensive Kuick Research Report Published at MarketPublishers.com 3Health News:Blue Cross and Blue Shield of Minnesota names Doctor On Demand as preferred telehealth destination 2Health News:Blue Cross and Blue Shield of Minnesota names Doctor On Demand as preferred telehealth destination 3Health News:World Negative Pressure Wound Therapy Market Assessed by GlobalData in In-demand Report Published at MarketPublishers.com 2Health News:World Negative Pressure Wound Therapy Market Assessed by GlobalData in In-demand Report Published at MarketPublishers.com 3
... joint venture with a South African company that will support ... joint venture between Ranbaxy and South Africa based Community Investment ... company to sell the drugs in Africa. The CEO of ... permit the company to make the drugs available at a ...
... Sydney have expressed hope over their newly developed drug ... is also claimed to improve the clinical outcome in ... and post transplant recipients. ,The unique drug ... promising results have been obtained. It has been found ...
... the effect of parental conflict on learning and behavioral ... to the consequent sleep disorders in children. //Although it ... parents lead to behavior and learning problems in children, ... new study, published in the latest issue of Child ...
... The bird flu’s virulent H5N1 strain has been discovered in ... Health (OIE). This has given rise to fears that a ... fist incidence of bird flu in the Continent. Preventive measures ... Nigerian authorities, with regard to animals and birds. ...
... disease buster might be now challenged. ,A University of Chicago ... grains had no reduced risk of two types of cancer or ... drawback of the study as perceived by some experts is that ... unhealthy food than the healthy foods., ,As said by Dr. ...
... parents are more likely to suffer from depression as ... are unmarried. Florida State University researchers, and researchers from ... this interesting finding. Researchers hypothesize that the constant concern ... adult children could be responsible for the same. ...
Cached Medicine News:Health News:Parental Conflict Can Lead to Sleep Disorders in Children 2Health News:Fat isn't all that bad: Reduction no predecessor of reduced disease 2Health News:Depression More Likely To Affect Parents, Rather Than Non-Parents 2
... WideBiter Punch series facilitates fast and effective ... smooth, anatomically shaped meniscal rim. The flat, ... to access even the tightest joint spaces. ... Inc., 20 years of engineering experience in ...
... series facilitates fast and effective resection of ... shaped meniscal rim. The flat, crescent-shaped tip ... even the tightest joint spaces. Made in ... years of engineering experience in arthroscopy hand ...
... fast and effective resection of meniscal tears ... rim. The flat, crescent-shaped tip has an ... tightest joint spaces. Made in the U.S. ... engineering experience in arthroscopy hand instrument design ...
... facilitates fast and effective resection of meniscal ... meniscal rim. The flat, crescent-shaped tip has ... the tightest joint spaces. Made in the ... of engineering experience in arthroscopy hand instrument ...
Medicine Products: