Krystexxa FDA Approval History
FDA Approved: Yes (First approved September 14, 2010)
Brand name: Krystexxa
Generic name: pegloticase
Dosage form: Injection
Company: Savient Pharmaceuticals, Inc.
Treatment for: Gout
Krystexxa (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Development timeline for Krystexxa
| Date | Article |
|---|
| Jul 8, 2022 | Approval FDA Approves Krystexxa (pegloticase) Injection Co-Administered With Methotrexate, Expanding the Labeling to Help More People with Uncontrolled Gout Achieve a Complete Response to Therapy |
| Sep 15, 2010 | Approval FDA Approves Krystexxa (pegloticase) for Gout |
| Mar 30, 2010 | Savient Announces Krystexxa Resubmitted BLA Accepted for Review by the FDA |
| Mar 19, 2010 | Savient Resubmits Biologics License Application for Krystexxa (pegloticase) for the Treatment of Chronic Gout in Patients Refractory to Conventional Therapy |
| Sep 19, 2009 | Savient Provides Update on Meeting with U.S. Food and Drug Administration for Krystexxa |
| Aug 4, 2009 | Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Krystexxa |
| Jun 17, 2009 | FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout |
| May 7, 2009 | Savient Announces New Date for FDA Arthritis Advisory Panel Review of Krystexxa for Treatment Failure Gout |
| Feb 12, 2009 | Savient Provides Update on Pegloticase BLA |
| Jan 28, 2009 | Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients |
| Dec 30, 2008 | Pegloticase BLA Filing Accepted for Priority Review by FDA |
| Oct 31, 2008 | Savient Submits Biologics License Application (BLA) for Pegloticase |
Further information
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