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Arcalyst FDA Approval History

Last updated by Judith Stewart, BPharm on March 30, 2021.

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; Deficiency of Interleukin-1 Receptor Antagonist; Recurrent Pericarditis

Arcalyst (rilonacept) is an interleukin-1 inhibitor indicated for the:

  • treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older
  • maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more
  • treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older.

Development timeline for Arcalyst

Mar 18, 2021Approval Kiniksa Announces FDA Approval of Arcalyst (rilonacept) for Recurrent Pericarditis
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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