|Target||complement component 1s|
|Other names||BIVV009, sutimlimab-jome|
|Main uses||Cold agglutinin disease (CAD)|
|Side effects||Respiratory tract infections, diarrhea, joint pain, peripheral swelling|
Sutimlimab, sold under the brand name Enjaymo, is a medication used to treat cold agglutinin disease (CAD). Specifically it is used to prevent the breakdown of red blood cells. It is given by gradual injection into a vein. People need to be vaccinated against encapsulated bacteria before it is started.
Common side effects include respiratory tract infections, diarrhea, joint pain, and peripheral swelling. Other side effects may include infections, infusion reactions, and autoimmune diseases. It is a monoclonal antibody that attaches to and blocks C1s.
Sutimlimab was approved for medical use in the United States and Europe in 2022. In the United States it costs about 280,000 USD per year for someone who weights 40 to 75 kg. It is not marketed in the United Kingdom.
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). It improves hemoglobin levels and decreases the need for blood transfusions in 73% of people compared to 15% with a placebo.
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.
Mechanism of action
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. All participants received sutimlimab for up to six months and could choose to continue therapy in a second part of the trial. 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.
In total, 54% of participants responded to sutimlimab. 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.
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). The applicant for this medicinal product is Genzyme Europe BV.
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