Press Releases

FDA approves expanded label of Enjaymo® (sutimlimab-jome) to include long-term safety and efficacy for people with cold agglutinin disease

Cambridge, MA, January 25, 2023. The US Food and Drug Administration (FDA) has approved the expanded indication for Enjaymo® (sutimlimab-jome), the first and only treatment of hemolysis in adults with cold agglutinin disease (CAD), to include patients with or without a history of transfusions. The efficacy supplemental Biologics License Application was evaluated under priority review and included long-term data from the pivotal CADENZA and CARDINAL studies.

Enjaymo was first FDA-approved in February 2022 based on data from Part A of the CARDINAL study, a single arm, open label study in patients with CAD with a recent blood transfusion (within the past 6 months).

Bill Sibold

Executive Vice President, Head of Specialty Care at Sanofi

“This milestone underscores our ongoing commitment to improve outcomes for the rare blood disorder community. As a first-in-class therapy, Enjaymo can help people living with cold agglutinin disease better manage their symptoms, including the impact of fatigue, which may positively affect their daily life.”

Expanded label supported by findings from CADENZA and CARDINAL

The expansion of the US prescribing information is based primarily on the Phase 3 CADENZA study, a double-blind, placebo-controlled clinical trial of adults with CAD, without a recent history of blood transfusion (within the past 6 months). The trial met its primary composite endpoint, demonstrating inhibition of hemolysis as well as avoidance of transfusions and use of CAD-related treatments. Secondary endpoint data showed an increase in hemoglobin levels, decrease in bilirubin levels, and decrease in lactate dehydrogenase (LDH) levels.

Patients receiving Enjaymo also reported a statistically significant improvement of symptoms and impacts of fatigue as measured by The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (LS mean difference of 8.93; 95% CI: 4.0-13.85, p <0.001). The overall safety results were consistent with the safety profile of Enjaymo from the CARDINAL study.

Part B of the CARDINAL and CADENZA studies demonstrated the long-term safety as well as durability of response to Enjaymo in patients with CAD over a 2-year follow up or 1-year follow up, respectively. In both CADENZA and CARDINAL studies, signs and symptoms of recurrent hemolysis were observed nine weeks after the last dose of Enjaymo in Part B. The most common adverse reactions in the CADENZA study (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud’s phenomenon. The most common adverse reactions in the CARDINAL study (incidence ≥25%) are urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea. Under the expanded label, Enjaymo is now also available in an undiluted preparation, which can decrease the bi-weekly infusion time to one hour.

A breakthrough treatment proven to help address impacts of CAD

Enjaymo is currently the only approved treatment of hemolysis for CAD. It is a first-in-class humanized monoclonal antibody that is designed to selectively target and inhibit the classical complement pathway specific serine protease, C1s. By blocking C1s of the classical complement pathway, Enjaymo inhibits C1-activated hemolysis in CAD to prevent hemolysis, while leaving the lectin and alternative pathways intact.



ENJAYMO® is a prescription medicine used to treat the breakdown of red blood cells (hemolysis) in adults with cold agglutinin disease (CAD). It is not known if ENJAYMO is safe and effective in children.


Do not receive ENJAYMO if you are allergic to sutimlimab-jome or any of the ingredients in ENJAYMO.

ENJAYMO can cause serious side effects, including:

  • Serious Infections: ENJAYMO is a prescription medicine that affects your immune system. ENJAYMO can lower the ability of your immune system to fight infections. People who take ENJAYMO may have an increased risk of getting infections caused by certain kinds of bacteria such as Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae. These infections may be serious or life-threatening. Some infections may quickly become life-threatening or cause death if not recognized and treated early.
    • You need to receive vaccinations against infections caused by certain kinds of bacteria at least 2 weeks before your first dose of ENJAYMO. You may need to have additional vaccinations during treatment.
    • If your healthcare provider decides that urgent treatment with ENJAYMO is needed, you should receive vaccinations as soon as possible.
    • Vaccinations may reduce the risk of these infections, but do not prevent all infections. Call your healthcare provider or get medical help right away if you get any new signs and symptoms of an infection, including:
      • fever 
      • severe headache with stiff neck or back
      • pain during urination or urinating more often than usual
      • cough or difficulty breathing
      • flu-like symptoms
      • pain, redness, or swelling of the skin
  • Infusion-related reactions: Treatment with ENJAYMO may cause infusion-related reactions, including allergic reactions that may be serious or life-threatening. Your healthcare provider may slow down or stop your ENJAYMO infusion if you have an infusion-related reaction and will treat your symptoms if needed. Tell your healthcare provider right away if you develop symptoms during your ENJAYMO infusion that may mean you are having an infusion-related reaction, including:
    • shortness of breath
    • decrease in blood pressure
    • chest discomfort
    • rapid heartbeat
    • nausea
    • injection site reaction
    • flushing
    • headache
    • dizziness
    • rash
    • itchy skin
  • Risk of autoimmune disease: ENJAYMO may increase your risk for developing an autoimmune disease such as systemic lupus erythematosus (SLE). Tell your healthcare provider and get medical help if you develop any symptoms of SLE, including:
    • joint pain or swelling
    • rash on the cheeks and nose
    • unexplained fever
  • If you have CAD and you stop receiving ENJAYMO, your healthcare provider should monitor you closely for the return of your symptoms after you stop ENJAYMO. Stopping ENJAYMO may cause the breakdown of your red blood cells due to CAD return. Symptoms or problems that can happen due to red blood cell breakdown include:
    • tiredness
    • shortness of breath
    • rapid heart rate
    • blood in your urine or dark urine

The most common side effects of ENJAYMO include:

  • increase in blood pressure
  • urinary tract infection
  • respiratory tract infection
  • bacterial infection
  • swelling in lower legs or hands
  • joint pain
  • headache
  • nausea
  • bluish color to the lips and skin
  • runny nose
  • dizziness
  • feeling tired or weak
  • cough
  • changes in color or sensation in the fingers and toes (Raynaud’s phenomenon)

These are not all the possible side effects of ENJAYMO. Call your doctor for medical advice about side effects.

Before receiving ENJAYMO, tell your healthcare provider about all of your medical conditions, including if you:

  • have a fever or infection, including a history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • have an autoimmune disease such as systemic lupus erythematosus (SLE), also known as lupus.
  • are pregnant or plan to become pregnant. It is not known if ENJAYMO will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ENJAYMO passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Please see full Prescribing Information, including Medication Guide.


About cold agglutinin disease  
CAD is a chronic and rare blood disorder that impacts the lives of an estimated 5,000 people in the US It is caused by antibodies called cold agglutinins binding to the surface of red blood cells, which starts a process that causes the body’s immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). Red blood cells have the vital job of carrying oxygen throughout the body, so people with CAD may experience severe anemia, which can result in fatigue, weakness, shortness of breath, light-headedness, chest pain, irregular heartbeat, and other potential complications.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY


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