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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.The application for sutimlimab received orphan drug, breakthrough therapy, and priority review designations. Society and culture
Legal status
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. Names
Sutimlimab is the International nonproprietary name (INN). References
External links
"Sutimlimab". Drug Information Portal. U.S. National Library of Medicine. Clinical trial number NCT03347396 for "A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)" at ClinicalTrials.gov