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 children (<12yrs), & FRONTIER4 OLE study assessing Mim8 (Q2W) & its long-term safety across all dosing regimens
- Mim8 is an FVIIIa-mimetic bispecific antibody that bridges Factor IXa & X to replace FVIIIa function, restoring thrombin generation & supporting normal blood clotting
Ref: Novo Nordisk | Image: Novo Nordisk | Press Release
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