The CHMP Recommends Novo’s Frehemgo (Denecimig) for Haemophilia A

Shots: The CHMP has recommended Frehemgo (QM, Q2W or QW) to treat haemophilia A, with or without inhibitors, in adults & children, based on the FRONTIER program; launch is expected in the first EU countries in Q4’26 & broadly across the EU starting early 2027 FRONTIER 2 trial showed Frehemgo significantly reduced annualized bleeding rates…

ByRidhi Rastogi3 days ago

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…

ByRidhi RastogiJuly 13, 2026

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…

ByRidhi RastogiSeptember 30, 2025

The CHMP Recommends Novo’s Frehemgo (Denecimig) for Haemophilia A

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

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

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