KrystexxaTreatment for Gout
Update: Krystexxa (pegloticase) Now FDA Approved - September 14, 2010
Arthritis Advisory Committee Recommends FDA Approval for Krystexxa
FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout
EAST BRUNSWICK, N.J., June 16 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. announced today that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended by a vote of 14 to 1 that Krystexxa (pegloticase), a biologic PEGylated uricase enzyme, be granted marketing approval by the FDA for the treatment of refractory chronic gout. Refractory chronic gout or treatment failure gout (TFG) is gout in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with conventional urate-lowering therapy at the maximum medically appropriate dose or for whom conventional urate-lowering therapy is contraindicated. The current target Prescription Drug User Fee (PDUFA) action date for the FDA's decision as to whether to grant marketing approval for Krystexxa is August 1, 2009.
"We are very pleased with the Advisory Committee's recommendation, which supports our belief that Krystexxa has a favorable risk to benefit profile in patients suffering from TFG," said Paul Hamelin, President of Savient Pharmaceuticals, Inc. "Krystexxa has the potential to provide an important new treatment option for patients with TFG, who currently have no other available treatment options, and many of whom suffer from serious pain and disability.
The Advisory Committee's recommendation, although not binding, will be considered by the FDA in its review of the Biologics License Application that Savient has submitted for Krystexxa.
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and marketing pharmaceutical products that target unmet medical needs in both niche and broader specialty markets. Savient is currently developing one product: Krystexxa (pegloticase) as a therapy for patients with treatment failure gout, to control hyperuricemia and to manage the signs and symptoms of gout. Savient has exclusively licensed worldwide rights to the technology related to Krystexxa, formerly referred to as Puricase(R), from Duke University and Mountain View Pharmaceuticals, Inc. Savient also manufactures and supplies Oxandrin(R) (oxandrolone tablets, USP) CIII in the U.S. Further information on Savient can be accessed by visiting: http://www.savient.com/. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.
All statements other than statements of historical facts included in this press release are forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond our control. Words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "will" and other similar expressions help identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding the efficacy and safety of Krystexxa (pegloticase), our BLA filing with the FDA, the Advisory Committee, approval of the BLA, preparation for commercialization of Krystexxa, and the market for Krystexxa, are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our assessment and interpretation of the currently available data and information, our Phase 3 clinical data and on current expectations, assumptions, estimates and projections about our business and the biopharmaceutical and specialty pharmaceutical industries in which we operate. Important factors that may affect our ability to achieve the matters addressed in these forward-looking statements include, but are not limited to, the possibility that the FDA may not approve our BLA for Krystexxa, notwithstanding the recommendation of the Advisory Committee; any delay or failure by us in completing the development of Krystexxa; varying interpretations of our clinical and CMC data by the FDA; difficulties in obtaining financing; potential development of alternative or more effective products by competitors; reliance on third parties to manufacture, market and distribute many of our products; economic, political and other risks associated with foreign operations; risks of maintaining protection for our intellectual property; risks of an adverse determination in intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical industry and other important factors set forth more fully in our reports filed with the Securities and Exchange Commission, to which investors are referred for further information. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements, which speak only as of the date of publication of this press release to shareholders. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We do not have a policy of updating or revising forward-looking statements and, except as required by law, assume no obligation to update any forward-looking statements.
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Source: Savient Pharmaceuticals, Inc.
Web Site: http://www.savient.com/
Posted: June 2009
- FDA Approves Krystexxa (pegloticase) for Gout - September 15, 2010
- Savient Announces Krystexxa Resubmitted BLA Accepted for Review by the FDA - March 30, 2010
- Savient Resubmits Biologics License Application for Krystexxa (pegloticase) for the Treatment of Chronic Gout in Patients Refractory to Conventional Therapy - March 19, 2010
- Savient Provides Update on Meeting with U.S. Food and Drug Administration for Krystexxa - September 19, 2009
- Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Krystexxa - August 4, 2009
- Savient Announces New Date for FDA Arthritis Advisory Panel Review of Krystexxa for Treatment Failure Gout - May 7, 2009
- Savient Provides Update on Pegloticase BLA - February 12, 2009
- Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients - January 28, 2009
- Pegloticase BLA Filing Accepted for Priority Review by FDA - December 30, 2008
- Savient Submits Biologics License Application (BLA) for Pegloticase - October 31, 2008