Difference between revisions of "Sutimlimab (Enjaymo)"
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Anti-C1s antibody | Anti-C1s antibody | ||
| − | == | + | ==Diseases for which it is used== |
| − | + | *[[Cold agglutinin disease]] | |
#'''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 | #'''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 | ||
#'''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] | #'''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== | ||
| + | *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)'' | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' BIVV009 | *'''Code name:''' BIVV009 | ||
| − | + | *'''Generic name:''' sutimlimab-jome | |
| + | *'''Brand name:''' Enjaymo | ||
| + | |||
[[Category:Drugs]] | [[Category:Drugs]] | ||
| + | [[Category:Intravenous medications]] | ||
[[Category:Anti-C1s antibodies]] | [[Category:Anti-C1s antibodies]] | ||
| − | [[Category:Cold agglutinin disease medications | + | [[Category:Cold agglutinin disease medications]] |
| − | [[Category: | + | [[Category:FDA approved in 2022]] |
Revision as of 10:31, 5 November 2022
Mechanism of action
Anti-C1s antibody
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. link to original article PubMed NCT03347396
- 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. link to original article PubMed
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)
Also known as
- Code name: BIVV009
- Generic name: sutimlimab-jome
- Brand name: Enjaymo