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Home > News > Manufacturer News > Sanofi's Enjaymo (Sutimlimab) Approved in the EU for the Treatment of Cold Agglutinin Disease (CAD)

Sanofi's Enjaymo (Sutimlimab) Approved in the EU for the Treatment of Cold Agglutinin Disease (CAD)

Author: Magicure Date: 2022-11-18

On November 17, Sanofi announced that the European Commission (EC) has granted marketing authorization for Enjaymo (sutimlimab) for the treatment of hemolytic anemia in adult patients with cold agglutinin disease (CAD). Enjaymo is the first-and-only approved therapeutic option approved for hemolytic anemia in adult patients with cold agglutinin disease.

Sanofi

Cold agglutinin disease (CAD) is a rare type of autoimmune hemolytic anemia, where part of the body’s immune system mistakenly destroys healthy red blood cells (hemolysis). CAD impacts the lives of an estimated 12,000 people in the US, Europe, and Japan and is associated with profound fatigue and increased risk of thromboembolic events and mortality.

The EC approval is based on data from two Phase 3 clinical trials: CADENZA, a double-blind, placebo-controlled clinical trial of adults with CAD without a recent history of blood transfusion (within the past 6 months), and CARDINAL, a 26-week open label, single-arm pivotal study in patients with CAD who have had a recent blood transfusion.

In the CADENZA Part A trial, eligible patients were randomized 1:1 to receive a fixed weight-based dose (6.5g or 7.5g) of Enjaymo or placebo via intravenous infusion on Day 0, Day 7, and then once every other week up to Week 26. The open-label Part B of the study assessed long-term safety as well as durability of response to Enjaymo in patients with CAD. 

In the CADENZA Part A study, Enjaymo met its primary composite endpoint and all secondary endpoints and demonstrated inhibition of hemolysis, increase in hemoglobin levels, and clinically meaningful improvement in The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores. Enjaymo demonstrated an acceptable safety profile and was generally well-tolerated

In the CARDINAL Part A trial, patients received a fixed weight-based dose (6.5g or 7.5g) of Enjaymo via intravenous infusion on Day 0, Day 7, and then once every other week up to Week 26. Part B of the study evaluated the long-term safety as well as durability of response to Enjaymo in patients with CAD over a 2-year follow up. 

In the CARDINAL Part A study, the efficacy of Enjaymo was assessed based on the achievement of a primary composite endpoint (Hb≥12 g/dL or an increase of at least 2 g/dL; no blood transfusion or prohibited medications from Weeks 5 through 26) and different secondary endpoints, including improvements in hemoglobin, normalization of bilirubin, and FACIT-fatigue score

About Enjaymo (sutimlimab)

Enjaymo (sutimlimab)

Enjaymo is a humanized monoclonal antibody that is designed to selectively target and inhibit C1s in the classical complement pathway, which is part of the innate immune system. By blocking C1s, Enjaymo inhibits the activation of the complement cascade in the immune system and inhibits C1-activated hemolysis in CAD to prevent the abnormal destruction of healthy red blood cells. Enjaymo does not inhibit the lectin and alternative pathways. 

Enjaymo was approved by the US Food and Drug Administration (FDA) in February 2022 as the first and only treatment indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD. The Japanese Ministry of Health, Labor and Welfare approved Enjaymo in June 2022. The European Medicines Agency (EMA) also made the decision to maintain orphan designation.

Disclaimer: The services of Hong Kong Magicure Medical Center do not replace a physician-patient relationship and are not intended as medical advice. Hong Kong Magicure Medical Center provides patients and physicians with new medicine options by providing safe and secure access to approved medicines from other countries. We only provide this service after the patient and physician have made a professional decision on the treatment.

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