EU Approves Novo Nordisk's Hemophilia A Preventive Treatment from Denmark
en.Wedoany.com Reported - On November 13, Denmark-based Novo Nordisk announced that its FREHEMGO (denecimig) has received marketing authorization from the European Commission for routine bleeding prevention in adult and pediatric patients with hemophilia A, including patients with factor VIII inhibitors and patients without inhibitors who have severe or moderate hemophilia A requiring prophylactic treatment. The drug is administered subcutaneously via a single-use prefilled injection pen, offering three dosing regimens: once monthly, once every two weeks, and once weekly.
FREHEMGO is a bispecific antibody that mimics the function of activated coagulation factor VIII (FVIIIa). Its active ingredient, denecimig, simultaneously binds activated coagulation factor IX (FIXa) and coagulation factor X (FX), mimicking the cofactor role of FVIIIa in the coagulation process, promoting the generation of activated coagulation factor X, and restoring thrombin generation capacity. Unlike conventional factor VIII replacement therapy, this drug connects key factors in the coagulation process through an antibody-mediated mechanism and is suitable for certain patients with factor VIII inhibitors.
The EU approval was primarily based on Novo Nordisk's FRONTIER clinical research program. FRONTIER2 evaluated the once-monthly and once-weekly dosing regimens in patients aged 12 years and older; FRONTIER3 studied children under 12 years of age; and FRONTIER4, an open-label extension study, further evaluated the once-every-two-weeks dosing regimen and long-term safety across different dosing frequencies. Novo Nordisk disclosed that the FRONTIER2 trial showed that denecimig reduced the annualized bleeding rate compared with prior factor prophylaxis and on-demand treatment, and that the pediatric results from FRONTIER3 were consistent with the efficacy observed in adolescent and adult patients.
The FRONTIER5 study focused on evaluating safety and injection device experience after patients directly switched from emicizumab to denecimig prophylaxis. The company disclosed that no new safety signals were identified, and patients showed a high preference for the denecimig prefilled injection pen. Common adverse reactions listed in the European Medicines Agency's previously published review opinion include injection site reactions, elevated prothrombin fragment 1.2, and elevated D-dimer.
The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive review opinion on September 17, 2026, recommending approval of the drug, and the European Commission subsequently granted formal marketing authorization. FREHEMGO had previously been approved in Saudi Arabia and is currently under review by the U.S. Food and Drug Administration and other regulatory authorities. Novo Nordisk plans to launch market supply in the first batch of European countries within the next year.
