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Emicizumab, a bispecific antibody that bridges factor IXa and factor X to mimic factor VIII activity, has transformed hemophilia A prophylaxis. Now, phase 3 data are available on Mim8 (denecimig), an investigational, next-generation agent with the same mechanism as emicizumab but substantially greater thrombin-generation potency.
This industry-sponsored trial involved 254 patients aged ≥12 years with hemophilia A (84% severe; 12% with inhibitors). The patients were split into two cohorts: The 58 patients receiving on-demand treatment before the trial were randomized to continue that treatment or receive Mim8 weekly or monthly. The rest were given clotting factor concentrate during a run-in phase and then randomized to Mim8 either week…