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Monday, March 16, 2020

Novo Nordisk suspends three concizumab studies on safety signal

Citing three cases of non-fatal thrombotic (clotting) events, Novo Nordisk (NVO -5.2%) has suspended three clinical trials evaluating concizumab for the prophylactic treatment of hemophilia A & B patients regardless of inhibitor status.
The three studies are two Phase 3s, EXPLORER 7 & 8, and a Phase 2, EXPLORER 5.
Recruitment will cease as will treatment of patients already enrolled.
The company and the independent Data Monitoring Committee are assessing the situation but no decisions on a path forward have been made yet.
Concizumab is a subcutaneously administered anti-tissue factor pathway-inhibiting monoclonal antibody that the company says allows the body to generate adequate amounts of factor Xa to ensure effective hemostasis.

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