Wikipedia

Sutimlimab

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]

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

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]

Medical uses

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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][3]

Adverse effects

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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.[3] In two phase 3 studies (n=66), 29% of patients experienced infusion-related reactions, including shortness of breath, rapid heartbeat, nausea, flushing, headache, hypotension, chest discomfort, pruritis, rash, injection site reaction, and dizziness.[10]

Pharmacology

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Mechanism of action

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Sutimlimab targets the C1s enzyme and inhibits its enzymatic propagation of the classical complement pathway, thereby, preventing the formation of the C3-convertase enzyme.[11]

History

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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.[3] All participants received sutimlimab for up to six months and could choose to continue therapy in a second part of the trial.[3] Based on body weight, participants received either a 6.5 g or 7.5 g infusion of sutimlimab into their vein on day 0, day 7, and every 14 days through week 25.[3]

In total, 54% of participants responded to sutimlimab.[3] 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.[3]

The US Food and Drug Administration (FDA) granted the application for sutimlimab orphan drug,[3][12] breakthrough therapy,[3] and priority review designations.[3]

Society and culture

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In September 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Enjaymo, intended for the treatment of hemolytic anemia in adults with cold agglutinin disease (CAD).[13] The applicant for this medicinal product is Genzyme Europe BV.[13] Sutimlimab was approved for medical use in the European Union in November 2022.[2][14]

Names

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Sutimlimab is the International nonproprietary name (INN).[15]

References

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  1. ^ a b c d "Enjaymo- sutimlimab injection, solution, concentrate". DailyMed. 1 February 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022.
  2. ^ a b c d "Enjaymo EPAR". European Medicines Agency (EMA). 14 September 2022. Retrieved 4 March 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. ^ 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. 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.
  4. ^ 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.
  5. ^ 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.
  6. ^ "Sutimlimab FDA Approval Status". FDA. 19 May 2020. Archived from the original on 31 December 2021. Retrieved 31 December 2021.
  7. ^ "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.
  8. ^ "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.
  9. ^ 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.
  10. ^ FDA Professional Drug Information
  11. ^ 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.
  12. ^ "Sutimlimab Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 27 July 2016. Archived from the original on 7 February 2022. Retrieved 6 February 2022.
  13. ^ a b "Enjaymo: Pending EC decision". European Medicines Agency (EMA). 15 September 2022. Archived from the original on 16 September 2022. Retrieved 18 September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. ^ "Enjaymo Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  15. ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information. 32 (3). hdl:10665/330907.
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  • 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 ClinicalTrials.gov
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