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Arcalyst FDA Approval History

FDA Approved: Yes (First approved February 27, 2008)
Brand name: Arcalyst
Generic name: rilonacept
Dosage form: Injection
Previous Name: Interleukin-1 Trap
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Cryopyrin-Associated Periodic Syndromes

Arcalyst (rilonacept) is an interleukin-1 inhibitor for the long-term treatment of Cryopyrin-Associated Periodic Syndromes (CAPS).

Development Timeline for Arcalyst

Feb 28, 2008Approval FDA Approves Arcalyst - New Orphan Drug for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Nov  2, 2007PDUFA Date for Rilonacept (IL-1 Trap) Extended Three Months by FDA
Aug  8, 2007Rilonacept (IL-1 Trap) Granted FDA Priority Review for the Treatment of CAPS
Jun  8, 2007Regeneron Submits Biologics License Application to U.S. FDA for IL-1 Trap (Rilonacept) for Treatment of CAPS

Further information

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