FDA News

Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS

(Aug 07, 2007)-- Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review status to the Biologics License Application (BLA) for rilonacept, the Interleukin-1 (IL-1) Trap, for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). The FDA has previously granted Orphan Drug status and Fast Track designation to rilonacept for the treatment of CAPS.

The FDA grants priority review to drugs that may offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious or life-threatening disease. Under priority review status, a target date is established for the FDA to complete their review of a BLA within six months from their receipt of the submission. The FDA is expected to take action on the rilonacept application by the end of November 2007. Currently, there are no medicines approved for patients suffering from CAPS, a spectrum of rare inherited inflammatory conditions, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

"The FDA's decision to grant priority review to rilonacept underscores the need for an effective therapy for patients suffering from this serious, debilitating disease," said Leonard S. Schleifer, M.D., Ph.D., president and chief executive officer of Regeneron. "Acceptance of the BLA filing brings us one step closer to our goal of providing the first approved treatment for patients with CAPS. We look forward to continuing to work with the FDA during their ongoing review of our marketing application."

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