Sutimlimab: First Approval

 

Declarations

Funding The preparation of this review was not supported by any external funding.  

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sohita Dhillon is a contracted employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.  

Additional information about this Adis Drug Review can be found here.  

Abstract 

Sutimlimab (sutimlimab-jome; ENJAYMO™) is a humanized monoclonal antibody developed by Sanofi for the treatment of cold agglutinin disease (CAD). Sutimlimab is an immunoglobulin G, subclass 4 (IgG4) monoclonal antibody that inhibits the classical complement pathway by binding to complement protein component 1, s subcomponent (C1s), a serine protease which cleaves C4 and C2 to form the C3 convertase. Inhibition of the classical complement pathway at the level of C1s prevents deposition of complement opsonins on the surface of red blood cell (RBCs), leading to inhibition of haemolysis in patients with CAD. In February 2022, sutimlimab received its first approval in the USA to decrease the need for RBC transfusion due to haemolysis in adults with CAD. Sutimlimab is under regulatory review in Japan and the EU for CAD. This article summarizes the milestones in the development of sutimlimab leading to this first approval for CAD. 

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