Denmark-based Novo Nordisk A/S (NYSE: NVO) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for its Alhemo (concizumab-mtci) injection. The drug is indicated as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with inhibitors. This FDA approval follows endorsements in Australia, Japan, Switzerland, and the European Union.
Alhemo’s Mechanism of Action and Clinical Efficacy
Alhemo is an anti-tissue factor pathway inhibitor (TFPI) monoclonal antibody (mAb) that enhances the production of thrombin, a protein crucial for blood clotting and preventing bleeding, especially when other clotting factors are missing or deficient in the presence of inhibitors. The FDA’s decision is supported by the results from the Phase III explorer7 study, which demonstrated an 86% reduction in the annual bleeding rate (ABR) for patients receiving Alhemo prophylaxis compared to those without prophylaxis. Notably, 64% of patients receiving Alhemo prophylaxis experienced zero treated spontaneous and traumatic bleeds during the first 24 weeks of treatment, compared to 11% in the group without prophylaxis.-Fineline Info & Tech
