Sutimlimab

Sutimlimab
Monoclonal antibody
TypeWhole antibody
SourceChimeric/humanized hybrid
Targetcomplement component 1s
Names
Trade namesEnjaymo
Other namesBIVV009, sutimlimab-jome
Clinical data
Main usesCold agglutinin disease (CAD)[1]
Side effectsRespiratory tract infections, diarrhea, joint pain, peripheral swelling[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Routes of
use		Intravenous infusion
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status

Sutimlimab, sold under the brand name Enjaymo, is a medication used to treat cold agglutinin disease (CAD).[1] Specifically it is used to prevent the breakdown of red blood cells.[2] It is given by gradual injection into a vein.[1] People need to be vaccinated against encapsulated bacteria before it is started.[1]

Common side effects include respiratory tract infections, diarrhea, joint pain, and peripheral swelling.[1] Other side effects may include infections, infusion reactions, and autoimmune diseases.[1] It is a monoclonal antibody that attaches to and blocks C1s.[2]

Sutimlimab was approved for medical use in the United States and Europe in 2022.[1][2] In the United States it costs about 280,000 USD per year for someone who weights 40 to 75 kg.[3] It is not marketed in the United Kingdom.[3]

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][4] It improves hemoglobin levels and decreases the need for blood transfusions in 73% of people compared to 15% with a placebo.[2]

Dosage

It is initially given once per week for two weeks and than every two weeks.[2] For those who weight 39 to 75 kg the dose is 6,500 mg and for those who weight more than 75 kg the dose is 7,500 mg.[1]

Side 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.[4]

Pharmacology

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.[5]

History

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.[4] All participants received sutimlimab for up to six months and could choose to continue therapy in a second part of the trial.[4] 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.[4]

In total, 54% of participants responded to sutimlimab.[4] 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.[4]

The application for sutimlimab received orphan drug,[4][6] breakthrough therapy,[4] and priority review designations.[4] It is being developed by Bioverativ, a Sanofi company.[7]

Society and culture

On 15 September 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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).[8] The applicant for this medicinal product is Genzyme Europe BV.[8]

Names

Sutimlimab is the International nonproprietary name (INN).[9]

References

  1. 1 2 3 4 5 6 7 8 9 10 11 "Enjaymo- sutimlimab injection, solution, concentrate". DailyMed. 1 February 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022.
  2. 1 2 3 4 5 "Enjaymo". Archived from the original on 6 December 2022. Retrieved 11 December 2022.
  3. 1 2 "Sutimlimab". SPS - Specialist Pharmacy Service. 19 October 2018. Archived from the original on 5 July 2022. Retrieved 11 December 2022.
  4. 1 2 3 4 5 6 7 8 9 10 "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. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ↑ 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.
  6. ↑ "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.
  7. ↑ "Sutimlimab FDA Approval Status". FDA. 19 May 2020. Archived from the original on 31 December 2021. Retrieved 31 December 2021.
  8. 1 2 "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.
  9. ↑ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information. 32 (3). hdl:10665/330907.
External sites:
Identifiers:
  • 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
This article is issued from Offline. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.