Novo Nordisk has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for FREHEMGO (denecimig) to treat haemophilia A in adults and children.
The recommendation covers people with haemophilia A (HA), including those with and without inhibitors. If approved, FREHEMGO could provide a new routine treatment option to help prevent or reduce bleeding episodes in people living with the inherited bleeding disorder.
FREHEMGO is a next-generation factor VIIIa mimetic bispecific antibody developed by Novo Nordisk for routine prophylaxis. The treatment is designed to provide protection against bleeding while offering flexible dosing and a prefilled pen delivery system.
The CHMP opinion is based on results from Novo Nordisk’s FRONTIER clinical trial programme. In the pivotal FRONTIER 2 trial, denecimig significantly reduced the annualised bleeding rate compared with participants’ previous clotting factor prophylaxis and on-demand treatment.
Results from the FRONTIER 3 trial in children younger than 12 years were consistent with the results seen in adolescents and adults. Across the FRONTIER programme, Novo Nordisk reported low mean annualised bleeding rates, generally below one treated bleed per year in the reported Phase 3 population. A substantial number of participants had no treated bleeding episodes.
The company also evaluated patients who switched directly from emicizumab to denecimig prophylaxis in the FRONTIER 5 trial. Novo Nordisk said the study identified no new safety signals following the switch. Participants also showed a preference for the denecimig delivery device.
Mike Doustdar, president and CEO of Novo Nordisk, said the CHMP recommendation marks an important step in the company’s work in haemophilia, an area where it has more than 40 years of experience.
He said the combination of bleeding protection, flexible dosing and a prefilled pen could offer people with haemophilia A another option while helping reduce the burden of regular treatment.
The positive CHMP opinion will now move to the next stage of the European Union’s marketing authorisation process. A final decision will determine whether FREHEMGO can be marketed for haemophilia A in the EU.
Novo Nordisk is also pursuing regulatory approval in the US. The company submitted denecimig to the US Food and Drug Administration (FDA) in September 2025 through a Biologics License Application (BLA).