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Novo-Nordisk

Novo Nordisk Reveals Long-Term Data from P-III (FRONTIER4) Trial of Mim8 for Haemophilia A at ISTH 2026

Shots: Novo Nordisk has reported P-III (FRONTIER4) extension study data assessing Mim8 (denecimig, SC) prophylaxis in paediatric & adult pts with hemophilia A, with or without inhibitors, across a range of dosing frequencies incl. QM, Q2W, & QW Interim data (n=426) showed Mim8’s safety was consistent with prior studies, while efficacy EPs demonstrated low mean ABRs…

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Novo Nordisk

Novo Nordisk Reports the US FDA’s BLA Submission of Mim8 (Denecimig) for Haemophilia A with or without Inhibitors

Shots: The US FDA has accepted the BLA for Mim8 (denecimig; pre-filled, single-use pen) as routine prophylaxis to prevent or reduce bleeding episodes in adult & pediatric pts with hemophilia A (congenital FVIII deficiency), with or without inhibitors BLA was supported by FRONTIER2 trial assessing Mim8 (QW/QM) in pts (≥12yrs), FRONTIER3 trial assessing it in…

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