FDA Approves Krystexxa for Treatment-Resistant Gout

Author: U.S. Food and Drug Administration
Published: 2010/09/15 - Updated: 2025/05/27
Publication Details: Peer-Reviewed, Announcement
Category Topic: FDA News and Approvals - Academic Publications

Page Content: Synopsis - Introduction - Main - Insights, Updates

Synopsis: This report details the U.S. Food and Drug Administration's approval of Krystexxa (pegloticase), a new treatment for adults with gout who do not respond to or cannot tolerate standard therapies. The information is authoritative, as it originates from the FDA and references clinical trial data involving 212 patients, which showed significant reductions in uric acid levels and uric acid crystal deposits in joints and soft tissue. Krystexxa is administered intravenously every two weeks and works by metabolizing uric acid into a harmless compound excreted in urine, offering a valuable alternative for the approximately 3% of gout sufferers unhelped by conventional drugs.

The report is particularly useful for seniors and people with disabilities, who are more likely to experience gout or have comorbidities that limit treatment options. However, it also highlights the need for caution, as about 25% of trial participants experienced severe allergic reactions, necessitating pre-infusion medications and a Risk Evaluation and Mitigation Strategy to ensure patient safety - Disabled World (DW).

Introduction

The U.S. Food and Drug Administration has approved Krystexxa (pegloticase), manufactured by Savient Pharmaceuticals Inc. of East Brunswick, N.J., to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy.

Main Content

Gout occurs due to an excess of the bodily waste uric acid, which is eventually deposited as needle-like crystals in the joints or in soft tissue. These crystals can cause intermittent swelling, redness, heat, pain and stiffness in the joints.

Gout is strongly associated with obesity, high blood pressure, high cholesterol and diabetes, and occurs more often in men, in women after menopause, and in people with kidney disease.

"About 3 percent of the three million adults who suffer from gout are not helped by conventional therapy. This new drug offers an important new option for them," said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

For patients with gout, the conventional therapy is to receive drugs that lower the amount of uric acid in the blood, as, for example, the xanthine oxidase inhibitors Zyloprim (allopurinol) and Uloric (febuxostat). Krystexxa is an enzyme that lowers uric acid levels by metabolizing it into a harmless chemical that is excreted in the urine. The drug is administered to patients every two weeks as an intravenous infusion.

Two six-month clinical trials of 212 total patients demonstrated that the drug lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue.

Since one out of every four patients in the clinical trials experienced a severe allergic reaction when receiving an infusion of Krystexxa, health care providers should dispense a corticosteroid and an antihistamine to their patients beforehand to minimize the risk of such a reaction. Other reactions during the clinical trials included gout flare, nausea, injection site bruising, irritation of the nasal passages, constipation, chest pain and vomiting.

Physicians are also being warned to be cautious about administering Krystexxa to patients with congestive heart failure because the drug was not studied in this patient population.

Krystexxa is being approved with a Risk Evaluation and Mitigation Strategy that includes a medication guide for patients and materials for healthcare providers to communicate the risk of severe infusion and allergic reactions.

Insights, Analysis, and Developments

Editorial Note: The FDA's approval of Krystexxa marks a significant advance for those with treatment-resistant gout, a group often left with limited options and persistent pain. While the therapy introduces new hope, it also underscores the importance of careful patient selection and monitoring due to the risk of serious allergic reactions. This development not only broadens the therapeutic landscape for gout but also reinforces the need for tailored care in populations with complex health profiles - Disabled World (DW).

Attribution/Source(s): This peer reviewed publication was selected for publishing by the editors of Disabled World (DW) due to its relevance to the disability community. Originally authored by U.S. Food and Drug Administration and published on 2010/09/15, this content may have been edited for style, clarity, or brevity.

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Cite This Page: U.S. Food and Drug Administration. (2010, September 15 - Last revised: 2025, May 27). FDA Approves Krystexxa for Treatment-Resistant Gout. Disabled World (DW). Retrieved October 31, 2025 from www.disabled-world.com/medical/pharmaceutical/fda/gout-drug.php

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