Novo Nordisk FREHEMGO (Denecimig, Factor VIIIa-Mimetic Bispecific Antibody) Receives Positive EU CHMP Opinion for Hemophilia A With or Without Inhibitors; Once-Monthly, Every-Two-Week, and Weekly SC Dosing Options
Novo Nordisk (NYSE: NVO; Copenhagen: NOVO-B) received Thursday September 17, 2026 a positive EU CHMP opinion recommending marketing authorization for FREHEMGO (denecimig), the company's next-generation factor VIIIa-mimetic bispecific antibody, for treatment of hemophilia A (with or without factor VIII inhibitors) in adults and children. Denecimig offers flexible subcutaneous dosing including once-monthly, every-two-week, or weekly administration in a prefilled-pen presentation. Approval would position denecimig as the second bispecific-antibody FVIIIa mimetic in the European hemophilia A market after Roche's Hemlibra (emicizumab, first launched 2018) — potentially the first meaningful bispecific competition Roche has faced in the Hemlibra franchise. Novo Nordisk expects to launch denecimig in the first European countries in Q4 2026, with broader EU rollout beginning early 2027. The CHMP recommendation is based on data from the Phase 3 FRONTIER program including FRONTIER-2 (adults) and FRONTIER-4 (pediatric) trials. Sandoz-mAbxience separately announced Friday a Hemlibra-referenced biosimilar collaboration, adding a second layer of long-term competitive pressure to the Roche franchise.