“About 3% of 3 million adults who suffer from gout are not helped by conventional therapy. This new drug offers an important new option for them,” Badrul Chowdhury, MD, Director of the Division of Pulmonary, Allergy and Rheumatology Products FDA Center for Drug Evaluation and Research, said in a press release.Krystexxa, which is made by Savient Pharmaceuticals Inc. of East Brunswick, New Jersey, is an enzyme that lowers levels of uric acid by metabolizing a chemical that does not cause physical damage and is then passed through the urine.
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The FDA has approved Krystexxa (pegloticase) for the treatment of gout.
Krystexxa has few side effects. A quarter of patients who participated in clinical trials experienced a serious new drug. The FDA recommends that health care professionals to provide patients with a corticosteroid and an antihistamine to reduce the risk of an allergic reaction. Other reactions during clinical trials included gout, nausea, injection site bruising, irritation of the nose, chest pain, and vomiting.
Physicians should exercise caution when administering to patients with this condition Krystexxa as has not been formally studied.
Gout occurs when uric acid accumulates in the body, forming crystals in the joints or soft tissues. The crystals cause swelling, redness, pain and stiffness. The condition is associated with,,, and diabetes. Gout is more common in men and postmenopausal women and people with the disease.
Two six-month clinical trial of 212 patients in total have shown that the drug reduces the levels of uric acid and reduced deposits of uric acid crystals in joints and soft tissues. Savient expects Krystexxa to be available by prescription later this year. New option for the treatment of gout