Novo Nordisk reports positive long-term data for hemophilia A therapy
Experimental subcutaneous drug denecimig demonstrated consistent safety and efficacy across diverse dosing schedules in a phase 3 extension study. The findings, presented at the International Society on Thrombosis and Haemostasis Congress, show the treatment effectively prevents bleeding in children and adults regardless of inhibitor status.
The FRONTIER4 study followed 426 patients, including children as young as one, over a median observation period of up to six months. Researchers reported that injection-site reactions remained rare and mild, with no clinical evidence of neutralizing antibodies detected. Efficacy metrics proved robust, as 71% of adults and adolescents, and 89% of children, experienced zero treated bleeds throughout the duration of the study.
Beyond safety and bleeding control, patient-reported outcomes highlighted a significant reduction in treatment burden. Participants reported ease of use with the provided pen-injector, and those aged 12 and older noted improvements in joint pain. Novo Nordisk, which submitted the drug for FDA review last year, also shared results from the explorer10 trial, where concizumab achieved an 82% reduction in annualized bleeding rates for children with hemophilia A or B compared to on-demand treatment.
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