Novo Nordisk Halts Phase III Concizumab Hemophilia Trials After Three Thrombotic Events
No new patients will be enrolled, and trial participants will stop treatment with the tissue factor pathway inhibitor antibody, a class with four prior suspended hemophilia programs.
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With GLP-1 sales increasing by 31% in the third quarter, Novo Nordisk has raised its sales and operating profit outlooks for 2020 to 5-8% at CER, and has outlined promising R&D progress against atherosclerosis and obesity.
Novo Nodisk's CSO says FDA approval of extended half-life Factor VIII Esperoct treatment for people with hemophilia A will give more choice to those patients and "effectively completes" the Danish group's hitherto R&D efforts based on clotting factor deficiencies.
Genentech/Roche's Hemlibra, now FDA-approved for hemophilia A patients with inhibitors, offers a once-weekly injection, impressive efficacy with a safety concern that appears to be manageable, and a price that's at least half the cost of the established prophylaxis regimen.