Navigation Links
Savient Announces New Date for FDA Arthritis Advisory Panel Review of KRYSTEXXA(TM) for Treatment Failure Gout
Date:5/7/2009

EAST BRUNSWICK, N.J., May 7 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that its biologics license application (BLA) for KRYSTEXXA(TM) (pegloticase), a novel biological drug for treatment failure gout (TFG) patients, will be reviewed by the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) on June 16, 2009.

In December, the FDA accepted the Company's BLA for KRYSTEXXA and granted priority review status, which is a designation assigned to drugs that are deemed by the FDA to have the potential to provide an important advancement in treatment or provide a treatment for a disease or condition for which there is no adequate therapy available.

In January, the Company submitted to the FDA several key amendments for the KRYSTEXXA BLA to further strengthen and clarify the overall BLA application. The FDA reviewed and accepted the amendments and determined that the additional information contained in the submissions constituted major amendments. In an effort to include the amendments as part of the review, the FDA elected to extend the BLA review period and assigned a revised PDUFA date of August 1, 2009.

ABOUT KRYSTEXXA(TM)

KRYSTEXXA(TM) (pegloticase) is a pegylated recombinant mammalian urate oxidase in development to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective. The two Phase 3 pivotal trials assessed the safety and efficacy of a six-month course of pegloticase therapy in patients with treatment failure gout, under the auspices of an SPA from the FDA. KRYSTEXXA was granted orphan drug indication by the FDA in 2001. Savient's KRYSTEXXA BLA filing includes data from both the six-month placebo-controlled Phase 3 piv
'/>"/>

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

Page: 1 2 3 4

Related biology technology :

1. Savient Pharmaceuticals Reports First Quarter 2009 Financial Results
2. Savient Pharmaceuticals to Raise $31 Million Through Registered Direct Offering
3. Savient Pharmaceuticals to Hold Fourth Quarter and Year-End 2008 Results Conference Call on Thursday, February 26, 2009
4. Savient Announces Appointment of David Gionco as Chief Financial Officer
5. Savient Pharmaceuticals to Present at the Lazard Capital Markets 5th Annual Healthcare Conference on November 18th
6. Savient Pharmaceuticals Reports Third Quarter 2008 Financial Results
7. Savient Submits Biologics License Application (BLA) for pegloticase
8. Savients Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
9. Savient Pharmaceuticals to Hold Third Quarter 2008 Financial Results Conference Call on Thursday, November 6, 2008
10. Rib-X Pharmaceuticals Announces Presentations at the 19th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
11. GeoVax Labs, Inc. Announces First Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... how the receptors responsible for contractions in the bladder, ... published today in The FASEB Journal , has ... cycle of all cells in the body. The team ... and its control are weakened in ageing bladders, demonstrating ... ageing. , While currently much is known ...
(Date:8/22/2014)... August 22, 2014 Ophthalmic drug ... interesting and challenging endeavors as the anatomy, physiology ... properties to the foreign substances. Ocular drug delivery ... self medication and minimal use of needles; also ... drugs and provides specific targeting within the ocular ...
(Date:8/22/2014)... The AMA is pleased to share ... Alaska that Alaska Governor Sean Parnell has signed House ... public use of Unmanned Aircraft Systems and the continuation ... 255states that it is, “An Act relating to unmanned ... unmanned aircraft system.” It defines State of Alaska laws ...
(Date:8/21/2014)... LYNBROOK, N.Y. , Aug. 21, 2014 /PRNewswire/ ... a biopharmaceutical company developing first in class collagenase-based ... histolyticum or CCH) in the U.S. and XIAPEX ... statistically significant results from a randomized, double-blind Phase ... of cellulite, or edematous fibrosclerotic panniculopathy. The results ...
Breaking Biology Technology:Treatment for overactive bladder and irritable bowel syndrome advanced through pioneering research 2Ocular Drug Delivery Technologies Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Ocular Drug Delivery Technologies Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3Ocular Drug Delivery Technologies Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 4State of Alaska Signs Unmanned Aircraft Systems Bill 2BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 2BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 3BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 4BioSpecifics Technologies Corp. Announces Positive Data from Phase 2a Study of CCH for Treatment of Cellulite 5
... , , NEW YORK, Sept. ... with Dave Champagne, Vice President and General Manager of Informatics ... Chief Engineer at HUNT Research Center and Biobank, about data ... and challenges at life sciences companies. , ...
... , , BALTIMORE, Sept. 9 ... a company engaged in the development of advanced preclinical platforms and ... present at Rodman & Renshaw,s Eleventh Annual Healthcare Conference taking place ... The company,s Chairman of the Board, Dr. David Sidransky, will present ...
... 9 Oramed Pharmaceticals,Inc. (OTCBB: ORMP.OB), a developer of ... approval from the Institutional Review Board (IRB),to commence human ... was,granted after successful pre-clinical results were reported. The trials ... Center in,Jerusalem. , Currently, all ...
Cached Biology Technology:Don't Wait to Innovate: Future Pharmaceuticals Magazine Releases Its Issue on Innovation in IT, Cell-Based Therapy and Supply Chains 2Champions Biotechnology to Present at Rodman & Renshaw's Eleventh Annual Healthcare Conference 2Champions Biotechnology to Present at Rodman & Renshaw's Eleventh Annual Healthcare Conference 3Oramed Pharmaceuticals Commences Human Clinical Trials of an Oral GLP-1 Analog 2Oramed Pharmaceuticals Commences Human Clinical Trials of an Oral GLP-1 Analog 3
(Date:8/22/2014)... Access to Research Careers) Program has announced the travel ... Practical Exercises Workshop which will be held on the ... 2014. These awards are meant to help support ... groups in the the FASEB Grant Writing Seminar & ... awards totaling $20,350. , The FASEB MARC Program is ...
(Date:8/22/2014)... Green tea polyphenols are strong antioxidants and ... protect spinal cord neurons against oxidative stress? ... Affiliated Hospital of Liaoning Medical University, China ... oxidative stress and inhibit neuronal apoptosis, indicating ... in spinal cord neurons under oxidative stress. ...
(Date:8/21/2014)... in smog-producing toxins in past decade, GTA still ... shows that while the Greater Toronto Area (GTA) ... contribute to smog, the city continues to violate ... which can cause or aggravate health problems such ... by a set of complex photochemical reactions involving ...
Breaking Biology News(10 mins):Despite a significant reduction in smog-producing toxins, the Greater Toronto Area still violates Canada's standards for ozone air pollution 2
... reconstructions of atmospheric CO2 concentrations and sea level over ... National Oceanography Centre, Southampton have found that greenhouse gas ... million) were systematically associated with sea levels at least ... determined the ,natural equilibrium, sea level for CO2 concentrations ...
... learn that plants grow toward the light. This seems straightforward, ... to grow and move in response to their environment are ... most fundamental processes in plant biologyplant movement in response to ... American Journal of Botany . Plant movements, known ...
... have cast doubt on the widely held perception that ... Blooms, or proliferations, of jellyfish can show a substantial, ... fishermen, stinging waters for tourists, even choked cooling intake ... have created a perception that the world,s oceans are ...
Cached Biology News:New study documents the natural relationship between CO2 concentrations and sea level 2Scientists join forces to bring plant movement to light 2Scientists join forces to bring plant movement to light 3Scientists join forces to bring plant movement to light 4Jellyfish experts show increased blooms are a consequence of periodic global fluctuations 2
Gap junction protein, beta 2, 26kDa (connexin 26) Antigen: Peptide...
IKKbeta/IKK-2 Polyclonal Antibody 100 ug affinity purified rabbit polyclonal antibody. Reacts with human. Tested in Western blotting....
...
Request Info...
Biology Products: