FDA approves new drug for tough-to-treat goutSep-16-2010
The U.S. Food and Drug Administration approved the use of Savient Pharmaceuticals Inc's gout drug in adults who do not respond to other treatments or cannot take alternatives for various reasons.
"About 3 percent of the three million adults who suffer from gout are not helped by conventional therapy," said Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, in a prepared statement.
The mainstay of treatment for gout, in which buildup of uric acid causes swollen joints, is allopurinol.
The new drug, Krystexxa, is given every two weeks intravenously. In two six-month clinical trials in a total of 212 patients, the drug lowered uric acid levels and reduced deposits of uric acid crystals in joints and elsewhere.
However, one in four patients had severe allergic reactions during the infusions, and some experienced gout flares, nausea, injection site bruising, irritation of the nasal passages, constipation, chest pain and vomiting.
The drug was denied approval last year by the FDA because of manufacturing issues, and will carry a black-box warning regarding allergic reactions.
Savient expects the drug to be available by prescription in the United States later this year.
Posted by Clay Kohut at 12:00 AM -
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