Difference between revisions of "Sutimlimab (Enjaymo)"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
 
(12 intermediate revisions by the same user not shown)
Line 2: Line 2:
 
Anti-C1s antibody
 
Anti-C1s antibody
  
==Preliminary data==
+
==Diseases for which it is used==
#'''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
+
*[[Cold agglutinin disease]]
  
=Investigational agents=
+
==History of changes in FDA indication==
*[[Sutimlimab (BIVV009)]]
+
*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==
[[Category:Cold agglutinin disease regimens]]
+
*2022-11-15: Enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with [[Cold agglutinin disease|cold agglutinin disease (CAD)]].
[[Category:Disease-specific pages]]
+
==History of changes in PMDA indication==
[[Category:Complementopathies]]
+
*2022-06-20: A drug with a new active ingredient indicated for the treatment of [[cold agglutinin disease]].
[[Category:Hemolytic process]]
 
  
 
==Also known as==
 
==Also known as==
*'''Code name:''' BIVV009
+
*'''Code name:''' BIVV-009
 
+
*'''Generic name:''' sutimlimab-jome
 +
*'''Brand name:''' Enjaymo
 +
 
[[Category:Drugs]]
 
[[Category:Drugs]]
 +
[[Category:Intravenous medications]]
 
[[Category:Anti-C1s antibodies]]
 
[[Category:Anti-C1s antibodies]]
[[Category:Investigational drugs]]
+
 
 +
[[Category:Cold agglutinin disease medications]]
 +
 
 +
[[Category:EMA 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