Global InformationSutimlimab information
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric/humanized hybrid |
| Target | complement component 1s |
| Clinical data | |
| Trade names | Enjaymo |
| Other names | BIVV009, sutimlimab-jome |
| License data |
|
| Routes of administration | Intravenous infusion |
| Drug class | Complement inhibitor |
| ATC code |
|
| Legal status | |
| Legal status |
|
| Identifiers | |
| CAS Number |
|
| UNII |
|
| KEGG |
|
Sutimlimab, sold under the brand name Enjaymo, is a monoclonal antibody that is used to treat adults with cold agglutinin disease (CAD).[1][3][4] It is given by intravenous infusion.[1] Sutimlimab prevents complement-enhanced activation of autoimmune human B cells in vitro.[5]
The most common side effects include headache, high blood pressure, urinary tract infection (infection of the structures that carry urine), upper respiratory tract infection (nose and throat infection), nasopharyngitis (inflammation of the nose and throat), nausea, abdominal pain, infusion-related reactions and cyanosis (bluish discoloration of hands and feet in response to cold and stress).[2]
This medication is being developed by Bioverativ, a Sanofi company.[6] Sutimlimab was approved for medical use in the United States in February 2022,[3][7] and in the European Union in November 2022.[2] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[8][9]
- ^ a b c "Enjaymo- sutimlimab injection, solution, concentrate". DailyMed. 1 February 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022.
- ^ a b c Cite error: The named reference
Enjaymo EPARwas invoked but never defined (see the help page). - ^ a b "FDA approves treatment for adults with rare type of anemia". U.S. Food and Drug Administration. 4 February 2022. Archived from the original on 6 February 2022. Retrieved 6 February 2022.
This article incorporates text from this source, which is in the public domain.
- ^ Tvedt TH, Steien E, Øvrebø B, Haaverstad R, Hobbs W, Wardęcki M, et al. (February 2022). "Sutimlimab, an investigational C1s inhibitor, effectively prevents exacerbation of hemolytic anemia in a patient with cold agglutinin disease undergoing major surgery". American Journal of Hematology. 97 (2): E51–E54. doi:10.1002/ajh.26409. PMID 34778998. S2CID 244116614.
- ^ Nikitin PA, Rose EL, Byun TS, Parry GC, Panicker S (February 2019). "C1s Inhibition by BIVV009 (Sutimlimab) Prevents Complement-Enhanced Activation of Autoimmune Human B Cells In Vitro". Journal of Immunology. 202 (4): 1200–1209. doi:10.4049/jimmunol.1800998. PMC 6360260. PMID 30635392.
- ^ "Sutimlimab FDA Approval Status". FDA. 19 May 2020. Archived from the original on 31 December 2021. Retrieved 31 December 2021.
- ^ "FDA approves Enjaymo (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease". Sanofi (Press release). 4 February 2022. Archived from the original on 5 February 2022. Retrieved 6 February 2022.
- ^ "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain.
- ^ New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. This article incorporates text from this source, which is in the public domain.
