Novo Nordisk’s FREHEMGO Receives Positive CHMP Opinion for Haemophilia A
Novo Nordisk has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation for FREHEMGO® (denecimig) for the treatment of haemophilia A (HA) in adults and children, including people with or without inhibitors.
The recommendation marks an important regulatory milestone for denecimig, a next-generation factor VIIIa mimetic bispecific antibody being developed as a routine prophylactic treatment for people living with haemophilia A. If the European Commission grants the recommended marketing authorisation, FREHEMGO could provide another prophylaxis option designed to prevent or reduce the frequency of bleeding episodes while offering flexible dosing and a prefilled delivery device.
The CHMP opinion is supported by results from Novo Nordisk’s FRONTIER clinical development programme, which evaluated denecimig across different patient populations and treatment settings. Data from the programme have demonstrated low annualised bleeding rates, including in the pivotal phase 3 population, while a substantial proportion of participants experienced no treated bleeding episodes.
The regulatory recommendation also follows findings from studies evaluating denecimig in children and in patients switching from another non-factor therapy.
FREHEMGO Designed for Routine Haemophilia A Prophylaxis
Haemophilia A is a genetic bleeding disorder associated with insufficient or impaired factor VIII activity, which is required for normal blood clotting. People with the condition can experience spontaneous or trauma-related bleeding, including bleeding into joints and muscles.
Regular prophylactic treatment is used to reduce the risk of bleeding and protect patients from the cumulative consequences of repeated bleeding episodes. Treatment options include replacement factor therapies and non-factor-based medicines.
FREHEMGO, or denecimig, is being developed as a next-generation factor VIIIa mimetic bispecific antibody. Its intended use is routine prophylaxis in people with haemophilia A, both those with inhibitors and those without inhibitors.
By reducing bleeding frequency through prophylactic treatment, therapies such as denecimig are intended to help people with haemophilia A maintain better control over their condition and reduce the impact of recurrent bleeding on daily life.
The CHMP recommendation represents a step toward potentially expanding the range of prophylactic approaches available to people with haemophilia A in Europe.
FRONTIER Programme Provides Clinical Evidence
The positive CHMP opinion is based on the results generated across the FRONTIER clinical trial programme.
In the pivotal FRONTIER 2 study, denecimig significantly reduced the annualised bleeding rate compared with patients’ prior clotting factor prophylaxis and on-demand treatment. The trial included people with haemophilia A with or without inhibitors.
Annualised bleeding rate is an important measure in haemophilia clinical studies because it provides an estimate of how frequently patients experience bleeding episodes over a one-year period. Lower bleeding rates indicate greater control of bleeding during prophylaxis.
According to Novo Nordisk, denecimig demonstrated consistently low mean annualised bleeding rates across the FRONTIER programme. In the reported phase 3 population, these rates were generally below one bleeding episode per year.
The company also reported that a substantial proportion of participants experienced zero treated bleeds while receiving denecimig prophylaxis.
These results form a central part of the clinical evidence supporting the European regulatory application and highlight the potential of denecimig to provide sustained protection against bleeding across a broad haemophilia A population.
Pediatric Data Support Broader Use
The FRONTIER programme also includes data evaluating denecimig in younger patients.
Results from FRONTIER 3, which enrolled children younger than 12 years of age, were consistent with the efficacy observed in adolescents and adults. The findings provide additional clinical evidence for the use of denecimig across different age groups.
The inclusion of pediatric populations is particularly relevant for haemophilia A because the disease is a lifelong condition and treatment often begins during childhood. Effective prophylaxis during the early stages of life can play an important role in reducing bleeding-related complications and supporting physical activity and development.
Novo Nordisk’s data from FRONTIER 3 therefore contribute to the broader evidence base supporting denecimig in children as well as adult patients.
The company said the findings across the programme demonstrate consistently low mean annualised bleeding rates, with many participants experiencing no treated bleeding episodes.
Switching Study Evaluated Transition from Emicizumab
Another component of the FRONTIER programme, FRONTIER 5, evaluated patients who directly switched from emicizumab prophylaxis to denecimig.
The study found no new safety signals following the direct transition to denecimig prophylaxis. This finding provides additional information on the treatment experience for patients moving between non-factor prophylactic approaches.
FRONTIER 5 also evaluated patient preferences regarding the delivery device. According to Novo Nordisk, participants showed a clear preference for the denecimig device.
The company is developing FREHEMGO with a prefilled pen, which is intended to offer a convenient method of administration. Device design can be an important consideration in haemophilia management because prophylactic treatment may require repeated administration over long periods.
The combination of a prefilled pen, flexible dosing frequency and bleeding protection is being positioned by Novo Nordisk as an important aspect of the potential treatment option.
Novo Nordisk Highlights Treatment Flexibility
Mike Doustdar, president and CEO of Novo Nordisk, said the CHMP recommendation builds on the company’s more than four decades of involvement in haemophilia.
According to Doustdar, the recommendation represents an important development for people living with haemophilia A, regardless of inhibitor status. He highlighted the combination of bleeding protection, flexible dosing and a prefilled pen as features that could distinguish FREHEMGO as a treatment option.
The company is also emphasizing the potential of denecimig to reduce treatment burden. For people managing a chronic bleeding disorder, treatment administration and the frequency of prophylaxis can be significant considerations alongside efficacy and safety.
Novo Nordisk’s development strategy for denecimig therefore focuses not only on reducing bleeding but also on providing a delivery approach intended to offer greater flexibility in routine disease management.
Potential European Regulatory Milestone
The CHMP’s positive opinion is an important stage in the European medicines approval process, but it is not itself the final marketing authorisation. Following the CHMP recommendation, the European Commission will make the final decision on whether FREHEMGO can receive marketing authorisation in the European Union.
If approved, the decision would potentially make denecimig available as a prophylactic treatment for eligible adults and children with haemophilia A, including patients with or without inhibitors.
The regulatory review reflects the clinical data generated across the FRONTIER programme, including the pivotal FRONTIER 2 study, pediatric results from FRONTIER 3 and switching data from FRONTIER 5.
The overall findings reported by Novo Nordisk indicate that denecimig produced low annualised bleeding rates across the clinical development programme, with a substantial number of participants experiencing no treated bleeds.
U.S. Regulatory Review Also Underway
Novo Nordisk is pursuing regulatory review of denecimig beyond Europe. In September 2025, the company submitted the medicine to the U.S. Food and Drug Administration (FDA) through a Biologics License Application (BLA).
The U.S. submission represents another major regulatory step in the global development of denecimig. The company is therefore advancing the programme across major regulatory markets while continuing to build on evidence from the FRONTIER studies.
The European CHMP recommendation now provides a significant milestone in that international development programme. A final European Commission decision will determine whether FREHEMGO can proceed toward commercialization in the European Union.
Expanding Options for People With Haemophilia A
The potential introduction of denecimig comes as treatment approaches for haemophilia A continue to evolve beyond conventional factor replacement. Non-factor prophylaxis has expanded treatment possibilities for patients, including those with inhibitors, while innovations in administration are aimed at making long-term disease management more convenient.
The FRONTIER programme provides clinical data across adults, adolescents and children, as well as patients transitioning from another prophylactic therapy. The reported results indicate consistently low bleeding rates and a substantial proportion of patients with zero treated bleeds.
For Novo Nordisk, the positive CHMP opinion represents a continuation of its long-term focus on haemophilia and could bring a new treatment option closer to patients in Europe. The company will now await the European Commission’s final decision while its U.S. regulatory application remains part of the broader global development programme.
If approved, FREHEMGO could add another prophylactic approach for adults and children living with haemophilia A, with or without inhibitors, combining a factor VIIIa mimetic mechanism with flexible dosing and a prefilled pen designed to support routine treatment administration.
About the FRONTIER trials
The FRONTIER clinical programme includes FRONTIER1-5 and investigates denecimig as a prophylactic treatment to prevent bleeding episodes across paediatric and adult populations with haemophilia A, with or without inhibitors.
FRONTIER2, FRONTIER3 and FRONTIER4 formed the basis of the denecimig Marketing Authorisation Application (MAA) submission. 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; FRONTIER4 was an open-label extension trial evaluating the efficacy of denecimig once every two weeks (Q2W) as well as investigating the long-term safety of denecimig across all dosing regimens (once every month, once every two weeks, and once every week) in subjects with haemophilia A, with or without inhibitors.
About FREHEMGO® (denecimig)
FREHEMGO® (denecimig) is an FVIIIa mimetic bispecific antibody designed with the aim to deliver once monthly, every two weeks and weekly prophylaxis for people living with haemophilia A, with or without inhibitors. FREHEMGO®, which is administered under the skin, ‘mimics’ the role of FVIIIa by bridging factor IXa and factor X. This action mimics the cofactor function of FVIIIa, which helps restore the body’s thrombin generation capacity, helping blood to clot. FREHEMGO® is currently pending marketing approval from the EMA and other regulatory authorities.
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