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FDA Approves Rilonacept for the Treatment of Rare Inflammatory Syndromes NEW YORK -- February 28, 2008 -- The US Food and Drug Administration (FDA) has approved rilonacept (Arcalyst) for the long-term treatment of two cryopyrin-associated periodic syndrome (CAPS) disorders: familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). The approved use is for adults and children ages 12 years and older. FCAS and MWS affect nearly 300 people in the United States, and 50% of CAPS cases are associated with a gene mutation in the CIAS 1 gene. The FDA based its approval on a clinical study conducted by the manufacturer, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, which demonstrated the safety and effectiveness of the drug. Using a daily diary questionnaire, 47 patients rated their signs and symptoms of CAPS, each on a scale of 0 (none or no severity) to 10 (very severe). Patients who were treated with rilonacept experienced a greater improvement in overall symptom scores compared with patients who took placebo, and the improvements were sustained over time with continued treatment. The most commonly reported side effects were injection-site reactions and upper respiratory infections. "[Rilonacept] offers new promise for this small patient population suffering disorders associated with CAPS," said Curt Rosebraugh, MD, MPH, Acting Director of the FDA's Office of Drug Evaluation II. "The Orphan Drug Act -- now in its 25th year -- has been tremendously successful in delivering effective treatments to patients with extremely rare -- but serious -- diseases." Rilonacept is not indicated for use in patients with neonatal-onset multi-system inflammatory disease, which is another CAPS disorder. Regeneron expects to launch rilonacept within 30 days. SOURCE: US Food and Drug Administration and Regeneron Pharmaceuticals, Inc. E-mail this page to a friend or colleague! To print, use this version