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
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