The U.S. Food and Drug Administration (FDA) has approved Enjaymo™ (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD). Enjaymo is the first and only approved treatment for people with CAD and works by inhibiting the destruction of red blood cells (hemolysis).
A global collaboration of hematologists, scientists, and 4 individuals living with vWD developed 11 new guidelines on the diagnosis and 8 additional guidelines for the management of vWD. This was all accomplished with the joint efforts of the American Society of Hematology (ASH), the International Society on Thrombosis and Haemostasis (ISTH), National Hemophilia Foundation (NHF), and World Federation of Hemophilia (WFH).
Novo Nordisk announced that the clinical trials in the concizumab phase 3 programme (explorer 6, 7 and 8) are being resumed. The clinical trials are investigating subcutaneous concizumab prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status. This follows pausing of the trials in March 2020 due to the occurrence of non-fatal thrombotic events in three patients enrolled in the ongoing phase 3 program.
HEMA Biologics, LLC, (“HEMA Biologics”) today announced that the U.S. Food and Drug Administration
(FDA) approved SEVENFACT® [coagulation factor VIIa (recombinant)-jncw] as the first new bypassing
agent in over 20 years for adults and adolescents (12 years of age and older) with hemophilia A and B with
inhibitors.