FDA Approves Krystexxa
FDA Approves Krystexxa (pegloticase) for Gout
ROCKVILLE, Md., Sept. 14, 2010--The U.S. Food and Drug Administration today approved Krystexxa (pegloticase) to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy.
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.
Krystexxa is manufactured by Savient Pharmaceuticals Inc. of East Brunswick, N.J.
#
Posted: September 2010
Related articles
- 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 - July 8, 2022
- 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
- FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout - June 17, 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
Krystexxa (pegloticase) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.