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Regeneron rilonacept grabs priority status

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Regeneron's BLA for its "Interleukin-1 Trap" agent rilonacept will reach its user fee goal "by the end of November 2007" following FDA's decision to grant priority review status to Regeneron's application, the firm reported Aug. 8. The company announced completion of its rolling BLA for rilonacept for treatment of Cryopyrin-Associated Periodic Syndromes, a spectrum of rare inherited inflammatory conditions, on June 8. Rilonacept was previously granted fast track and orphan drug designations; Regeneron estimates that there are 200 to 500 patients with CAPS in the U.S...

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