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FDA Rejects Rilonacept for Treatment of Gout Flares
The FDA's action does not affect the current indication of Arcalyst for the treatment of cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adults and children 12 years old and older.
Interleukin-1 (IL-1) blockade may interfere with the immune response to infections. Serious, life-threatening infections have been reported in patients taking rilonacept. Rilonacept should be discontinued if a patient develops a serious infection.
For more information, visit Regeneron's Web site.