Difference between revisions of "Sutimlimab (Enjaymo)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
 
*2/4/2022: Approved to decrease the need for red blood cell transfusion due to hemolysis (red blood cell destruction) in adults with [[Cold agglutinin disease|cold agglutinin disease (CAD)]]. ''(Based on CARDINAL)''
 
*2/4/2022: Approved to decrease the need for red blood cell transfusion due to hemolysis (red blood cell destruction) in adults with [[Cold agglutinin disease|cold agglutinin disease (CAD)]]. ''(Based on CARDINAL)''
 
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==History of changes in EMA indication==
 +
*11/15/2022: Initial authorization
 
==Also known as==
 
==Also known as==
 
*'''Code name:''' BIVV009
 
*'''Code name:''' BIVV009
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[[Category:Cold agglutinin disease medications]]
 
[[Category:Cold agglutinin disease medications]]
  
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[[Category:EMA approved in 2022]]
 
[[Category:FDA approved in 2022]]
 
[[Category:FDA approved in 2022]]

Revision as of 13:25, 31 December 2022

Mechanism of action

Anti-C1s antibody

Diseases for which it is used

History of changes in FDA indication

  • 2/4/2022: Approved to decrease the need for red blood cell transfusion due to hemolysis (red blood cell destruction) in adults with cold agglutinin disease (CAD). (Based on CARDINAL)

History of changes in EMA indication

  • 11/15/2022: Initial authorization

Also known as

  • Code name: BIVV009
  • Generic name: sutimlimab-jome
  • Brand name: Enjaymo