Navigation Links
Savient Pharmaceuticals Submits European Marketing Authorization Application for KRYSTEXXA®
Date:5/4/2011

EAST BRUNSWICK, N.J., May 4, 2011 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced that it has, through its wholly owned subsidiary, Savient Pharma Ireland Limited, delivered via courier to the European Medicines Agency (EMA) and the assigned co-rapporteurs, the Marketing Authorization Application (MAA) for KRYSTEXXA® (pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy. Currently there are no EMA approved treatments for this condition available in the European Union.

Savient's MAA delivery was timed to meet the EMA's designated May 6, 2011 submission date. The MAA submission will be reviewed under the EMA centralized licensing procedure for member states of the European Union, and the application includes clinical and safety data from Savient's pivotal Phase 3 studies and the Open Label Extension program of KRYSTEXXA.

"We remain committed to advancing care for patients who suffer from this devastating disease and the MAA submission for KRYSTEXXA demonstrates an important step forward in addressing a significant unmet medical need that currently exists in Europe," stated John H. Johnson, Chief Executive Officer of Savient. "While KRYSTEXXA is currently available in the United States, this submission reflects our belief that KRYSTEXXA will have a very important role in the future management of refractory chronic gout globally."

KRYSTEXXA became commercially available in the U.S. by prescription on December 1, 2010, and is the only FDA approved product specifically 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 m
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Savient Pharmaceuticals Names Seasoned Pharma Exec Richard Crowley EVP Biopharmaceutical Operations
2. Savient Pharmaceuticals to Present Multiple Abstracts at The European League Against Rheumatism (EULAR) 2011 Annual Congress
3. Savient Pharmaceuticals to Present at the Bank of America Merrill Lynch 2011 Health Care Conference
4. Savient Pharmaceuticals to Hold First Quarter 2011 Financial Results
5. Savient Pharmaceuticals to Present at the ROTH 23rd Annual OC Growth Stock Conference
6. Savient Pharmaceuticals to Present at the 31st Annual Cowen & Co. Health Care Conference
7. Savient Pharmaceuticals Announces U.S. Launch of KRYSTEXXA™; Reports Fourth Quarter and Year-End 2010 Financial Results
8. Savient Pharmaceuticals to Hold Fourth Quarter and Year-End 2010 Results Conference Call on Friday, February 25, 2011
9. Savient Closes Sale of $230 Million in Convertible Senior Notes
10. Savient Announces Proposed Offering of $125 Million in Convertible Senior Notes
11. Savient Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/28/2014)... Nov. 28, 2014 /CNW Telbec/ - Ergoresearch Ltd « Ergoresearch ... of Mrs. Dominique Boudreau who will hold ... Mrs. Dominique Boudreau was acting as corporate ... similar duties for more than seven years for Laboratoire ... January 2013.  Mrs. Boudreau replaces Mr. Greco who was ...
(Date:11/28/2014)... Kan. , Nov. 28, 2014 Aratana ... company focused on the licensing or acquisition, development and ... other companion animals, today announced that it will present ... Conference, to be held December 2-3, 2014, at the ... . Steven St. Peter , ...
(Date:11/28/2014)... 28, 2014 Alimera Sciences, Inc. (NASDAQ: ... that specializes in the research, development and commercialization ... Securities Purchase Agreement with Deerfield Management and certain ... will issue shares of preferred stock to Deerfield ... million upon the satisfaction of certain closing conditions. ...
Breaking Medicine Technology:Ergoresearch announces the appointment of its new Vice Président Finance 2Ergoresearch announces the appointment of its new Vice Président Finance 3Aratana Therapeutics to Present at the 26th Annual Piper Jaffray Healthcare Conference 2Alimera Sciences Announces Agreement with Deerfield Management for $50.0 Million Financing 2Alimera Sciences Announces Agreement with Deerfield Management for $50.0 Million Financing 3
... 2007 - The Waismann,Method today announced findings ... that 66 percent of individuals currently taking,Suboxone, ... they,cannot stop taking the drug without assistance, ... to treat,dependency to opiates including OxyContin, Vicodin, ...
... 2007 - A therapeutic,vaccine developed by the ... new hope for cancer patients. The results ... presented to an,international audience at the Annual ... (ASCO) in Chicago, USA. ASCO is the,most ...
Cached Medicine Technology:Waismann Method Survey Reveals Dependency Risk for People Using,Suboxone 2Vakzine Projekt Management Reports Positive Clinical Trial Results,With Their Therapeutic Prostate Cancer Vaccine VPM4001 2
(Date:11/28/2014)... 2014 Agein.com, the Internet’s premier anti-aging web ... of the foremost experts in the industry, is releasing its ... this winter. , “The official start of winter is still ... been hit with an icy blast. After one of the ... 2015 will usher in another brutal winter,” says Dr. Kevin ...
(Date:11/28/2014)... Brosix is always making changes to its ... a more efficient, effective, and secure experience. Most recently, ... 1. The ability to setup local servers for each ... service customers around the globe. , 2. The ability ... customers that require millions of users in one network. ...
(Date:11/28/2014)... FL (PRWEB) November 28, 2014 Dr. ... cosmetic dermatologists , announced the addition of Dr. Bridgit ... Nolan joins the practice after having completed her dermatology ... Medicine. , Dr. Walder invited Dr. Nolan ... in medicine, surgery and cosmetic dermatology. Not only does ...
(Date:11/28/2014)... York, New York (PRWEB) November 28, 2014 ... are continuing to move forward in New Jersey’s ... claims in a consolidated litigation established there is ... Case List updated on November 18th shows 1,293 ... was created for lawsuits that allege complications resulting ...
(Date:11/28/2014)... (PRWEB) November 28, 2014 Miami's Plastic ... website. Practice founder Dr. Jeffrey Epstein ... Created using a groundbreaking WordPress platform, the site is ... , Currently, up to 75% of all prospective ... ever, these people are logging on with smartphones, tablets, ...
Breaking Medicine News(10 mins):Health News:Agein Corporation, a Leading Anti-Aging Company, Releases Top Diet and Personal Care Tips for Preventing Dry Skin this Season 2Health News:Brosix Infrastructure Architecture Changes to Benefit Users 2Health News:Dr. Diane Walder Welcomes New Cosmetic Dermatologist to Practice 2Health News:Nearly 1,300 Mirena Lawsuits Now Filed in Consolidated New Jersey Litigation, Bernstein Liebhard LLP Reports 2Health News:Nearly 1,300 Mirena Lawsuits Now Filed in Consolidated New Jersey Litigation, Bernstein Liebhard LLP Reports 3Health News:Top Rhinoplasty Surgeon Launches Innovative Website 2
... Molecular & Cell Biology at Boston University Henry M. ... at Boston University School of Medicine discovered recently a ... expression. The study describing this work titled, "Mpk1 MAPK ... Termination," appears in the March 4 issue of ...
... new, rapid blood test that could lead to early ... thousands of people stricken with fungal meningitis, a leading ... closer to market with a recent collaboration between the ... "The ability to quickly identify yeast infection in ...
... 4 (HealthDay News) -- Children are more likely to ... playgrounds in their neighborhoods, researchers report. The study ... give their opinions about outdoor public spaces in their ... children spent watching television, using the computer and playing ...
... trial process in the United States is on shaky ... are increasingly defined by specific genetic and biologic markers ... therapies grow smaller and smaller. Coupled with skyrocketing costs ... are essential in bringing new and effective therapies to ...
... THURSDAY, March 3 (HealthDay News) -- More young people are ... engaging in same-sex encounters, according to a new report detailing ... from interviews with 13,500 men and women aged 15 to ... that more than half of young people under age 24 ...
... (HealthDay News) -- The brain,s so-called reward center actually responds ... causing fear, finds a new study in mice. The ... help explain why some people are thrill-seekers. Pleasurable or ... a bridge, can trigger the production of dopamine, a neurotransmitter ...
Cached Medicine News:Health News:Novel mechanism for control of gene expression revealed 2Health News:University of Nevada, Reno, teams with IMMY to make new life-saving blood test 2Health News:University of Nevada, Reno, teams with IMMY to make new life-saving blood test 3Health News:To bring effective therapies to patients quicker, use the team approach 2Health News:To bring effective therapies to patients quicker, use the team approach 3Health News:More Young People Delay Sex, Try Oral Sex First, CDC Says 2Health News:More Young People Delay Sex, Try Oral Sex First, CDC Says 3
Used during the performance of balloon dilation procedures to inflate and deflate the balloon and measure the pressure within the balloon during the procedure. Supplied sterile in peel-open packages....
... Diameter; 5.4 Fr Straight Channel; 33 or ... MRO-7 Integral Operating Ureteroscopes offer a small ... easy access to the ureter for diagnosis ... Fr) is ideal for large operating instruments, ...
Semi-Rigid Ureteroscope...
... ACMI DUR-8 Elite's 8.7 Fr shaft reaches ... comparable scope providing complete intrarenal access, ... smooth, lubricious outer covering and working channel ... And its patented torque-stable shaft construction, tight-bend ...
Medicine Products: