Novo Nordisk presents promising findings for haemophilia treatment
Ella Day | June 23, 2025 | News story | Medical Communications, Research and Development |Â Â Haematology, International Society on Thrombosis and Haemostasis Congres, Novo Nordisk, clinical trial data, haemophilia, market approvalÂ
Novo Nordisk has presented data indicating that a direct switch to Mim8 (denecimig) prophylaxis treatment from emicizumab without a need for a washout period was generally well-tolerated in people with haemophilia A with or without inhibitors. This adds to overall clinical findings for Mim8, based on the company’s FRONTIER trials, accelerating development towards market approval and access.
The results follow the phase 3 FRONTIERS5 trial of patients with haemophilia A which investigated the safety of switching from previous emicizumab prophylaxis treatment directly to Mim8 prophylaxis treatment using the Mim8 pen-injector. The safety profile of Mim8 was consistent with previous findings from FRONTIER phase 3 trials. Additionally, the patient reported outcome data indicated that 97% of users preferred the Mim8 pen-injector over their previous injection system.
The results were presented at the International Society on Thrombosis and Haemostasis Congress in Washington, DC, US, running 21 to 25 June.
Haemophilia is a rare inherited bleeding disorder that impairs the body’s ability to make blood clots, a process needed to stop bleeding. There are different types, A and B, characterised by the type of clotting factor protein that is defective or missing.
Mim8 is an investigational FVIIIa mimetic bispecific antibody designed to deliver sustained haemostasis. It bridges Factor IXa and Factor X, replacing FVIII function, which restores the body’s thrombin generation capacity and helps blood to clot.
Mim8 is not yet approved by regulatory authorities or available anywhere in the world. With these findings, Novo Nordisk expects to submit Mim8 for UK regulatory review in 2026.
Ella Day
23/6/25
Related Content
FDA approves Wegovy for treatment of MASH in adults with liver fibrosis
The US Food and Drug Administration (FDA) has granted accelerated approval for Wegovy (semaglutide) as …
BioMed X and Novo Nordisk partner on oral peptide drug delivery innovation
BioMed X has announced a new collaboration with Novo Nordisk to improve oral delivery of …
Pila Pharma raises SEK 20m to advance new oral obesity treatment
Swedish biotech, Pila Pharma, has raised nearly SEK 20m, equivalent to €1.7m in a capital …
