Difference between revisions of "Sutimlimab (Enjaymo)"

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m (Jwarner moved page Sutimlimab (BIVV009) to Sutimlimab (Enjaymo): FDA approval)
 
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==Diseases for which it is used==
 
==Diseases for which it is used==
 
*[[Cold agglutinin disease]]
 
*[[Cold agglutinin disease]]
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#'''CARDINAL:''' Röth A, Barcellini W, D'Sa S, Miyakawa Y, Broome CM, Michel M, Kuter DJ, Jilma B, Tvedt THA, Fruebis J, Jiang X, Lin S, Reuter C, Morales-Arias J, Hobbs W, Berentsen S. Sutimlimab in Cold Agglutinin Disease. N Engl J Med. 2021 Apr 8;384(14):1323-1334. [https://doi.org/10.1056/nejmoa2027760 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33826820/ PubMed] NCT03347396
 
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#'''CADENZA:''' Röth A, Berentsen S, Barcellini W, D'Sa S, Jilma B, Michel M, Weitz IC, Yamaguchi M, Nishimura JI, Vos JMI, Storek M, Wong N, Patel P, Jiang X, Vagge DS, Wardęcki M, Shafer F, Lee M, Broome CM. Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 2022 Sep 1;140(9):980-991. [https://doi.org/10.1182/blood.2021014955 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35687757/ PubMed]
 
  
 
==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)''
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*2022-02-04: 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)''
 +
==History of changes in EMA indication==
 +
*2022-11-15: Enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with [[Cold agglutinin disease|cold agglutinin disease (CAD)]].
 +
==History of changes in PMDA indication==
 +
*2022-06-20: A drug with a new active ingredient indicated for the treatment of [[cold agglutinin disease]].
  
 
==Also known as==
 
==Also known as==
−
*'''Code name:''' BIVV009
+
*'''Code name:''' BIVV-009
 
*'''Generic name:''' sutimlimab-jome
 
*'''Generic name:''' sutimlimab-jome
 
*'''Brand name:''' Enjaymo
 
*'''Brand name:''' Enjaymo
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[[Category:Cold agglutinin disease medications]]
 
[[Category:Cold agglutinin disease medications]]
  
 +
[[Category:EMA approved in 2022]]
 
[[Category:FDA approved in 2022]]
 
[[Category:FDA approved in 2022]]
 +
[[Category:PMDA approved in 2022]]

Latest revision as of 12:09, 19 August 2023

Mechanism of action

Anti-C1s antibody

Diseases for which it is used

History of changes in FDA indication

  • 2022-02-04: 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

History of changes in PMDA indication

Also known as

  • Code name: BIVV-009
  • Generic name: sutimlimab-jome
  • Brand name: Enjaymo
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