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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  rilonacept
Trade Name:  Arcalyst
Date Designated:  07/14/2020
Orphan Designation:  Treatment of pericarditis
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  03/18/2021 
Approved Labeled Indication:  Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older
Exclusivity End Date:    03/18/2028 
Exclusivity Protected Indication* :  Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older
Kiniksa Pharmaceuticals, Ltd.
c/o Kiniksa Pharmaceuticals Corp.
100 Hayden Avenue
Lexington, Massachusetts 02421
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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