FREHEMGO® (denecimig) approved in the EU for haemophilia A, with a choice of monthly, every-two-weeks or weekly dosing

• European Commission (EC) grants marketing authorisation for FREHEMGO® (denecimig) for haemophilia A (congenital FVIII deficiency), with or without inhibitors, in adults and children.
• FREHEMGO® is the first FVIIIa mimetic to offer once-monthly, once-every-two-weeks and once-weekly prophylaxis in a single-use pre-filled pen.
• Novo plans to launch FREHEMGO® in the first European countries in the year ahead.
  

Bagsværd, Denmark, 13 November 2026 – Novo today announced that the European Commission has granted marketing authorisation for FREHEMGO® (denecimig) as routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A (congenital FVIII deficiency), with or without inhibitors. The authorisation follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in September 2026.

FREHEMGO® is a next-generation FVIIIa mimetic bispecific antibody given as an injection under the skin. People with haemophilia A, with or without inhibitors, and their healthcare teams can choose between once-monthly, once-every-two-weeks or once-weekly dosing, using a single-use pre-filled pen.

“Living with haemophilia means constantly planning around the risk of bleeding, often from early childhood. Each advance in treatment gives people with haemophilia and their families more freedom to focus on other aspects of life” said Maria Elisa Mancuso, Medical Member of the Board of Directors of World Federation of Hemophilia (WFH) and Senior Hematology Consultant at the Centre for Thrombosis and Hemorrhagic Diseases of IRCCS Humanitas Research Hospital in Rozzano, Milan, Italy. “Having more treatment options to discuss with their clinicians allows people to consider what best fits their everyday lives—at school, at work, in sport and within their families—and make informed decisions that reflect their individual needs and priorities.”

The approval is based on results from the FRONTIER clinical trial programme. In the pivotal FRONTIER2 trial, denecimig significantly reduced annualised bleeding rates compared with prior clotting factor prophylaxis and on-demand treatment in people with haemophilia A, with or without inhibitors¹. In children younger than 12 years, results from FRONTIER3 were consistent with the efficacy seen in adolescents and adults². Across the FRONTIER programme, denecimig has shown consistently low mean annualised bleeding rates, with a substantial proportion of participants experiencing zero treated bleeds^1-3. In the FRONTIER5 trial, direct switching from emicizumab to denecimig showed no new safety signals, a clear preference for the denecimig pen over previous administration methods and a sustained increase in thrombin generation into the normal range over the treatment period, without causing thrombin levels that might pose a thrombotic risk^4,5.

“This approval reflects the strength and consistency of the FRONTIER programme, which showed strong bleed protection across adults and children, with and without inhibitors,” said Martin Holst Lange, Chief Scientific Officer and Executive Vice President of Research & Development at Novo. “It’s the result of many years of work by our scientists, the trial investigators and the people with haemophilia A who took part in our studies. Together, they have helped bring the haemophilia community a treatment option that minimises trade-offs in care.”

FREHEMGO® has also been approved in Saudi Arabia and is under review by the US Food and Drug Administration (FDA) and other regulatory authorities.

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What is haemophilia?

Haemophilia is a rare inherited bleeding disorder that impairs the body’s ability to make blood clots, a process needed to stop bleeding⁶. It is estimated to affect approximately 1,125,000 people worldwide⁷. There are different types of haemophilia, which are characterised by the type of clotting factor protein that is defective or missing⁶. Haemophilia A is caused by a missing or defective clotting Factor VIII (FVIII). Inhibitors are an immune system response to the clotting factors in replacement therapy. Currently, it is estimated that up to 30% of people living with severe haemophilia A develop inhibitors that can cause replacement therapies to stop working⁸.

About FREHEMGO® (denecimig)

FREHEMGO® (denecimig) is a FVIIIa mimetic bispecific antibody for routine prophylaxis in people living with haemophilia A, with or without inhibitors, offering once-monthly, once-every-two-weeks or once-weekly dosing^1-3. FREHEMGO®, which is administered under the skin using a single-use pre-filled pen, ‘mimics’ the role of FVIIIa by bridging Factor IXa and Factor X⁹. This action mimics the cofactor function of FVIIIa, which helps restore the body’s thrombin generation capacity, helping blood to clot⁹. FREHEMGO® is approved in the EU and Saudi Arabia.

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^2-4,10,11.

FRONTIER2, FRONTIER3 and FRONTIER4 formed the basis of the denecimig Marketing Authorisation Application (MAA) submission. FRONTIER2 evaluated denecimig once-monthly and once-weekly in adults and adolescents 12 years of age and older; FRONTIER3 evaluated denecimig once-monthly and once-weekly in children below the age of 12; FRONTIER4 was an open-label extension trial evaluating the efficacy of denecimig once-every-two-weeks as well as investigating the long-term safety of denecimig across all dosing regimens (once-monthly, once-every-two-weeks and once-weekly) in people with haemophilia A, with or without inhibitors^2,3,11. FRONTIER5 evaluated the safety of switching directly from emicizumab to denecimig prophylaxis, as well as device preference⁴.

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Contacts for further information

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References

1. Mancuso ME, Chan AKC, Shanmukhaiah C, et al. Mim8 Bispecific Antibody Prophylaxis in Hemophilia A with or without Inhibitors. N Engl J Med. 2026;394:1696-1709.
2. ClinicalTrials.gov. NCT05306418. A Research Study Looking at Mim8 in Children With Haemophilia A With or Without Inhibitors. Available at: https://clinicaltrials.gov/study/NCT05306418. Last accessed: November 2026.
3. ClinicalTrials.gov. NCT05685238. A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A. Available at: https://clinicaltrials.gov/study/NCT05685238. Last accessed: November 2026.
4. ClinicalTrials.gov. NCT05878938. A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5). Available at: https://clinicaltrials.gov/study/NCT05878938. Last accessed: November 2026.
5. Hermans C, Benson G, Matino D, et al. FRONTIER5: Safety and patient experience of a direct switch from emicizumab to denecimig (Mim8) in patients with haemophilia A with or without inhibitors. Journal of Thrombosis and Haemostasis. 2026.
6. MedlinePlus. Hemophilia. Available at: https://medlineplus.gov/genetics/condition/hemophilia/. Last accessed: November 2026.
7. Iorio A, Stonebraker JS, Chambost H, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males: A Meta-analytic Approach Using National Registries. Ann Intern Med. 2019;171:540-546.
8. Kim JY and You CW. The prevalence and risk factors of inhibitor development of FVIII in previously treated patients with hemophilia A. Blood Res. 2019;54:204-209.
9. Ostergaard H, Lund J, Greisen PJ, et al. A factor VIIIa-mimetic bispecific antibody, Mim8, ameliorates bleeding upon severe vascular challenge in hemophilia A mice. Blood. 2021;138:1258-1268.
10. ClinicalTrials.gov. NCT04204408. A Research Study Investigating Mim8 in People With Haemophilia A (FRONTIER1). Available at: https://clinicaltrials.gov/study/NCT04204408. Last accessed: November 2026.
11. ClinicalTrials.gov. NCT05053139. A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors. Available at: https://clinicaltrials.gov/study/NCT05053139. Last accessed: November 2026.