Treats chronic gout. BLA 125293, held by Horizon Pharma. Pegloticase.
As of Nov 13, 2026, BLA 125293 (Krystexxa), held by Horizon Pharma, was first approved by FDA on Sep 14, 2010, with 13 approved supplements and 0 published complete response letters.
KRYSTEXXA (pegloticase) is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout 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 medically appropriate dose or for whom these drugs are contraindicated. KRYSTEXXA (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 7, 2022 | Supplement 104Efficacy (new indication or use) · Priority review | Approved | |
| Sep 14, 2010 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Krystexxa8MG · injectable; injection | Pegloticase | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2026 | Supplement 116Labeling · Standard review | Approved | |
| Jul 7, 2022 | Supplement 104Efficacy (new indication or use) · Priority review | Approved | |
| Jul 13, 2018 | Supplement 92Labeling · Standard review | Approved | |
| Aug 10, 2017 | Supplement 90Labeling · Standard review | Approved | None posted |
| Sep 9, 2016 | Supplement 89Labeling · Standard review | Approved | |
| May 10, 2016 | Supplement 85Labeling · Standard review | Approved | |
| Apr 11, 2016 | Supplement 86REMS | Approved | |
| Jul 30, 2015 | Supplement 83REMS | Approved | |
| Jul 17, 2015 | Supplement 81Labeling · Standard review | Approved | |
| Oct 10, 2013 | Supplement 60Labeling · Standard review | Approved | |
| Apr 16, 2012 | Supplement 34Labeling · Standard review | Approved | |
| Apr 16, 2012 | Supplement 40Labeling · Standard review | Approved | |
| Oct 19, 2010 | Supplement 1Labeling · Standard review | Approved | |
| Sep 14, 2010 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
