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Monoclonal antibody
TypeWhole antibody
SourceChimeric/humanized hybrid
Targetcomplement component 1s
Clinical data
Trade namesEnjaymo
Other namesBIVV009, sutimlimab-jome
License data
Routes of
Intravenous infusion
ATC code
Legal status
Legal status
CAS Number

Sutimlimab, sold under the brand name Enjaymo, is a monoclonal antibody that is used to treat adults with cold agglutinin disease (CAD).[1][2][3] It is given by intravenous infusion.[1] Sutimlimab prevents complement-enhanced activation of autoimmune human B cells in vitro.[4]

This drug is being developed by Bioverativ, a Sanofi company.[5] Sutimlimab was approved for medical use in the United States in February 2022.[2][6]

Medical uses

Sutimlimab is indicated to decrease the need for red blood cell transfusion due to hemolysis (red blood cell destruction) in adults with cold agglutinin disease (CAD).[1][2]

Adverse effects

The most common side effects include respiratory tract infection, viral infection, diarrhea, dyspepsia (indigestion), cough, arthralgia (joint stiffness), arthritis, and swelling in the lower legs and hands.[2]


Sutimlimab is contraindicated with patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.[7]


Mechanism of action

Sutimlimab targets the C1s enzyme and inhibits its enzymatic propagation of the classical complement pathway, thereby, preventing the formation of the C3-convertase enzyme.[8]


The effectiveness of sutimlimab was assessed in a study of 24 adults with cold agglutinin disease who had a blood transfusion within the past six months.[2] All participants received sutimlimab for up to six months and could choose to continue therapy in a second part of the trial.[2] Based on body weight, participants received either a 6.5g or 7.5g infusion of sutimlimab into their vein on day 0, day 7, and every 14 days through week 25.[2]

In total, 54% of participants responded to sutimlimab.[2] The response was defined in the study as an increase in hemoglobin (an indirect measurement of the amount of red blood cells that are not destroyed) of 2 g/dL or greater (or to 12 g/dL or greater), and no red blood cell transfusions after the first five weeks of treatment; and no other therapies for cold agglutinin disease as defined in the study.[2]

The application for sutimlimab received orphan drug,[2][9] breakthrough therapy,[2] and priority review designations.[2]

Society and culture


Sutimlimab is the International nonproprietary name (INN).[10]


  1. ^ a b c d "Enjaymo- sutimlimab injection, solution, concentrate". DailyMed. 1 February 2022. Retrieved 20 February 2022.
  2. ^ a b c d e f g h i j k l "FDA approves treatment for adults with rare type of anemia". U.S. Food and Drug Administration. 4 February 2022. Retrieved 6 February 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ 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.
  4. ^ 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.
  5. ^ "Sutimlimab FDA Approval Status". FDA. 19 May 2020.
  6. ^ "FDA approves Enjaymo (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease". Sanofi (Press release). 4 February 2022. Retrieved 6 February 2022.
  7. ^ "Enjaymo Prescribing Information - FDA" (PDF).
  8. ^ Bartko J, Schoergenhofer C, Schwameis M, Firbas C, Beliveau M, Chang C, et al. (October 2018). "A Randomized, First-in-Human, Healthy Volunteer Trial of sutimlimab, a Humanized Antibody for the Specific Inhibition of the Classical Complement Pathway". Clinical Pharmacology and Therapeutics. 104 (4): 655–663. doi:10.1002/cpt.1111. PMC 6175298. PMID 29737533.
  9. ^ "Sutimlimab Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 27 July 2016. Retrieved 6 February 2022.
  10. ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information. 32 (3). hdl:10665/330907.

External links

  • "Sutimlimab". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT03347396 for "A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)" at