Novo Nordisk Submits Denecimig (Mim8) BLA for Hemophilia A

Novo Nordisk has announced the submission of a Biologics License Application (BLA) for denecimig (Mim8) as a prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital FVIIIa deficiency), with or without inhibitors.1

According to a September 29, 2025 press release from the Company, the submission is supported by results from the FRONTIER study program. If approved, denecimig would be the first FVIIIa mimetic with flexible once every month, once every 2 weeks, and once every week dosing in a pre-filled, single-use pen.1

"It is important that we continue to drive scientific advances in hemophilia A, and the FRONTIER program supports the potential of denecimig as a prophylaxis bleed treatment option for a range of patients across dosing frequencies, age groups, and condition severity, regardless of inhibitor status," said Anna Windle, Senior Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk.1 "A cornerstone of hemophilia treatment is to help prevent bleeding episodes, and this submission is another step forward in our long-standing mission to help improve care. If approved, denecimig's single-dose prefilled injector pen and flexible dosing schedule may better fit into the lives of people living with this challenging condition."

An investigational FVIIIa mimetic bispecific antibody, denecimig is designed with the aim to deliver once every month, once every 2 weeks, or once every week prophylaxis for people living with hemophilia A, with or without inhibitors. Administered under the skin, denecimig "mimics" the role of FVIIIa by bridging Factor IXa and Factor X, replacing FVIIIa function and helping to restore the body's thrombin generation capacity, helping blood to clot. Of note, the use of denecimig in people living with hemophilia A is investigational and not yet approved by any regulatory authorities worldwide.1

As described by Novo Nordisk, the FDA submission is grounded in the results from the FRONTIER study program, a comprehensive program of studies designed to establish the efficacy and safety profile of denecimig as a prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A, with or without inhibitors.1

The FRONTIER clinical program includes FRONTIER1-5 and investigates denecimig as a preventive bleed treatment across pediatric and adult populations with hemophilia A, with or without inhibitors. Specifically, FRONTIER2, FRONTIER3 and FRONTIER4 formed the basis of the denecimig BLA submission.1

FRONTIER2 evaluated denecimig treatment once every month and once every week in adults and adolescents 12 years of age and older; FRONTIER3 evaluated denecimig treatment once every month and once every week in children below the age of 12; and FRONTIER4 was an open label extension trial evaluating the efficacy of denecimig once every 2 weeks (Q2W) as well as investigating the long-term safety of denecimig across all dosing regimens.1

Safety and patient-reported outcomes data from FRONTIER5 were announced in June 2025. The 26-week, open-label safety study enrolled 61 adults and adolescents ≥12 years of age with hemophilia A and found switching to denecimig from emicizumab can be done safely without a washout period or loading dose.2

Data other studies in the phase 3 FRONTIER program are expected to be presented at upcoming conventions and publications in 2025 and 2026.2

References

1. Novo Nordisk. Novo Nordisk submits Biologics License Application (BLA) to FDA for Mim8; an investigational, prophylaxis treatment for people living with hemophilia A with or without inhibitors. September 29, 2025. Accessed September 29, 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916431&utm_medium=email&utm_source=newsletter&utm_campaign=2025-media-release&utm_content=nni-mim8-sci_inn

2. Livingston R. Denecimig Well-Tolerated in Hemophilia A After Switching from Emicizumab. June 23, 2025. Accessed September 29, 2025. https://www.hcplive.com/view/denecimig-well-tolerated-in-hemophilia-a-after-switching-from-emicizumab