Enjaymo (sutimlimab-jome) for CAD

Last updated Dec. 2, 2022, by Teresa Carvalho, MS

✅ Fact-checked by Joana Carvalho, PhD

What is Enjaymo for CAD?

Enjaymo (sutimlimab-jome), previously known as BIVV009 or TNT009, is an injectable antibody-based therapy used to reduce the need for red blood cell transfusions due to hemolysis, or red blood cell destruction, in adults with cold agglutinin disease (CAD).

It is the first treatment for CAD to be approved in both the U.S. and the EU.

The therapy was first developed by Bioverativ. However, the company and its assets were acquired in 2018 by Sanofi, which continues to develop and market the treatment.

How does Enjaymo work?

Enjaymo is a lab-made monoclonal antibody that works by selectively blocking C1 protein activity. C1 plays a central role in the classical complement pathway, which is overly active in CAD. That overactivation leads to hemolysis and anemia, or low red blood cell counts, which are responsible for most of the disease’s symptoms.

The complement system is a set of more than 30 blood proteins, mainly produced by the liver, that contribute to the body’s natural immune defenses. By suppressing only one of its pathways, Enjaymo ensures that the complement system is not completely inactive.

The therapy is expected to prevent chronic hemolysis, increase hemoglobin levels, and reduce or prevent the need for blood transfusions. Hemoglobin is the protein responsible for transporting oxygen in red blood cells.

For people with CAD, the medication is expected to reduce symptoms and disease burden, and improve quality of life.

Who can take Enjaymo?

Enjaymo was approved by the U.S. Food and Drug Administration in February 2022 to reduce the need for blood transfusions due to hemolysis in adults with CAD. It became the first approved therapy for this rare condition.

In Europe, the therapy’s approval for the same indication came nine months later, in November 2022. Japan is still considering whether or not to approve the therapy.

Who should not take Enjaymo?

Enjaymo is contraindicated, or not recommended, for patients who have allergic reactions, including severe and potentially life-threatening reactions, to:

  • the therapy’s active ingredient, sutimlimab-jome.
  • other inactive constituents of the product, such as polysorbate 80, sodium chloride, sodium phosphate dibasic heptahydrate, and sodium phosphate monobasic monohydrate.

How is Enjaymo administered?

Enjaymo is supplied in a clear to slightly milky, or uncolored to slightly yellow solution, which is given by infusion directly into the bloodstream (intravenously). The treatment is provided in single-dose vials containing 1,100 mg of the therapy’s active ingredient at a concentration of 50 mg/mL. The recommended doses are the following:

  • 6,500 mg, for people weighing 39 kg to less than 75 kg (about 86–165 pounds).
  • 7,500 mg, for those weighing 75 kg or more, or over 165 pounds.

Treatment should be given once weekly for the first two weeks, and every other week thereafter. The infusion period depends on the patient’s body weight, but it usually takes place over 1–2 hours.

Before administration, treatment should be diluted in a solution of sodium chloride (0.9%) to a total volume of 500 mL.

The medication should be stored in the refrigerator, between 2 to 8 C (36 to 46 F). Before administration, the medicine should be taken out of the fridge until it reaches room temperature, and then given within a period of eight hours.

Enjaymo in clinical trials

Phase 1 trial

The safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of Enjaymo were first investigated in 122 healthy volunteers and adults with complement-pathway-related diseases, including CAD, in a Phase 1 trial (NCT02502903). Pharmacokinetics refers to the therapy’s movement into, through, and out of the body, while pharmacodynamics assesses its effects on the body.

Enjaymo’s favorable safety profile and biological effects in CAD patients — including its suppression of the classical complement pathway, increase in hemoglobin levels, and improvement of hemolysis biomarkers — led to the beginning of two Phase 3 trials that ended up supporting the therapy’s approval.


The open-label, two-part, Phase 3 CARDINAL study (NCT03347396) evaluated the safety and effectiveness of Enjaymo in 24 adults with primary CAD who received at least one blood transfusion within six months of enrolling.

Participants received weight-based doses of the therapy once a week for the first two weeks, then every other week for another 24 weeks, totaling about six months of treatment.

Results from the study’s Part A showed that 54% of patients met the main goal of reaching target hemoglobin levels or showing a target level rise after six months, while not requiring blood transfusions after the study’s fifth week. The therapy was generally safe.

Enjaymo also reduced patient hospitalizations more than threefold, and the number of blood transfusions by 75%.

In Part B, the therapy was associated with a sustained normalizing of the levels of hemoglobin and bilirubin — a marker of hemolysis. Quality of life improvements also were sustained over one year of treatment; 86.4% of patients remained transfusion-free from six months to a year.


The two-part, placebo-controlled, Phase 3 CADENZA trial (NCT03347422) tested Enjaymo in 42 adult CAD patients with no recent history of a blood transfusion. Participants were assigned randomly to receive either the therapy, at the same regimen as in CARDINAL, or a placebo, for six months (Part A). After that, all participants received the therapy for an additional year (Part B).

Part A results showed the therapy was superior to a placebo at increasing hemoglobin levels, reducing the need for blood transfusions, and lowering the levels of several hemolysis biomarkers. It also resulted in greater improvements in quality of life and reduced anemia symptoms, such as weakness, shortness of breath, heart palpitations, and chest pain, compared with a placebo.

Common side effects of Enjaymo

The most common side effects associated with Enjaymo include:

  • respiratory tract infection.
  • viral infection.
  • diarrhea.
  • indigestion.
  • cough.
  • joint pain.
  • arthritis.
  • swelling.


Enjaymo may increase patients’ susceptibility to developing serious infections, including those caused by certain types of bacteria known as encapsulated bacteria. These bacteria include Neisseria meningitides, which causes a form of meningitis, Streptococcus pneumoniae, associated with pneumonia, and Haemophilus influenzae, which can cause a range of severe infections.

For this reason, patients should be vaccinated against encapsulated bacteria before starting treatment with Enjaymo and be regularly monitored for any signs of infection.

Allergic reactions

Patients may develop allergic reactions to Enjaymo. The treatment is not recommended for patients with allergies to its active substance or other treatment ingredients.

In case of life-threatening allergic reactions (anaphylaxis), Enjaymo should be stopped immediately and a healthcare professional should be informed right away.

Autoimmune diseases

Enjaymo may increase a patient’s risk of developing autoimmune diseases, such as systemic lupus erythematosus. For this reason, those taking Enjaymo should be monitored regularly for signs or symptoms of an autoimmune condition and treated accordingly.


Once treatment ends, patients should be monitored closely for any signs or symptoms of hemolysis. Physicians may consider restarting Enjaymo if these indications are present immediately after treatment is discontinued.

Use in pregnancy and breastfeeding

It is unknown if Enjaymo can affect the developing fetus or pass to breast milk. Patients who plan to become pregnant or breastfeed should talk with their healthcare team and only continue treatment during these periods if the potential benefit justifies the potential risks to the fetus or infant.


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