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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sutimlimab-jome
Trade Name: Enjaymo
Date Designated: 07/27/2016
Orphan Designation: Treatment of autoimmune hemolytic anemia
Orphan Designation Status: Designated/Approved
Bioverativ USA Inc. (a fully owned subsidiary of Sanofi)
951 Gateway Boulevard
South San Francisco, California 94080
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: sutimlimab-jome
Trade Name: Enjaymo
Marketing Approval Date: 02/04/2022
Approved Labeled Indication: To decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD)
Exclusivity End Date: 02/04/2029 
Exclusivity Protected Indication* :  To decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD)
2 Generic Name: sutimlimab-jome
Trade Name: Enjaymo
Marketing Approval Date: 01/25/2023
Approved Labeled Indication: treatment of hemolysis in adults with cold agglutinin disease (CAD)
Exclusivity End Date: N/A  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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