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 inhibitorsBLA was supported by FRONTIER2 trial assessing Mim8 (QW/QM) in pts (≥12yrs), FRONTIER3 trial assessing it in…