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Arcalyst Approval History

  • FDA approved: Yes (First approved February 27th, 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 History and FDA Approval Process 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

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