Sutimlimab

Unassigned

New Medicines

Primary cold agglutinin disease

Information

New molecular entity
Sanofi
Sanofi

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

First-in-class, humanised monoclonal antibody that selectively inhibits an upstream serine protease within the C1-complex in the complement pathway, so preventing downstream signalling cascades, which results in phagocytosis, inflammation and cell lysis.
Cold agglutinin disease is a type of autoimmune hemolytic anemia defined by the presence of cold autoantibodies (autoantibodies which are active at temperatures below 30°C). It represents an estimated 16-32% of AIHA, whose annual incidence is estimated to be between 1/35,000-1/80,000 in North America and Western Europe [1].
Primary cold agglutinin disease
Intravenous infusion

Evidence based evaluations