Novo Nordisk A/S: Mim8 prophylaxis treatment shown to be well-tolerated when switching from emicizumab in people with haemophilia A in new phase 3 data presented at the ISTH 2025 Congress

Core Insights - Novo Nordisk's investigational drug Mim8 shows promising results in the phase 3b FRONTIER5 trial, allowing a direct switch from emicizumab without a washout period, demonstrating good tolerability and no safety concerns in patients with haemophilia A [1][3][5] - The patient-reported outcomes indicate a strong preference for the Mim8 pen-injector over the previous emicizumab injection system, with high satisfaction regarding its ease of use [4][5] Group 1: Trial Results - The FRONTIER5 trial involved 61 adults and adolescents with haemophilia A, showing that switching to Mim8 was well-tolerated with no reported thromboembolic events or treatment-emergent adverse events leading to discontinuation [3][5] - A sustained increase in thrombin peak levels was observed after switching to Mim8, without an exaggerated thrombin response, indicating effective management of bleeding risk [2][6] Group 2: Patient-Reported Outcomes - 97% of patients expressed a "very strong" or "fairly strong" preference for the Mim8 pen-injector compared to emicizumab, highlighting significant user satisfaction [4] - 98% of participants found the Mim8 pen-injector "very easy" or "easy" to use, and 100% felt confident in using it correctly, suggesting a positive reception of the new delivery method [4][5] Group 3: Future Prospects - Novo Nordisk plans to submit Mim8 for regulatory review in 2025, with ongoing data from the FRONTIER programme to be shared at future congresses and publications [5][10] - The results from the FRONTIER5 trial contribute to the overall safety profile of Mim8, reinforcing its potential as a future treatment option for haemophilia A [5][6]