Novo: CHMP recommends EU approval of FREHEMGO® (denecimig), the first factor VIIIa mimetic offering monthly, once every two weeks and weekly dosing in a pre-filled pen, for the treatment of haemophilia A
CHMP backs Novo Nordisk’s denecimig, positioning FREHEMGO for EU launch as a flexible prophylactic option for haemophilia A.
Rhea-AI Summary
Novo Nordisk (NVO) received a positive CHMP opinion recommending EU marketing authorisation for FREHEMGO (denecimig) to treat haemophilia A with or without inhibitors in adults and children.
FREHEMGO is a factor VIIIa mimetic bispecific antibody for routine prophylaxis, offering once‑monthly, once‑every‑two‑weeks and once‑weekly dosing in a single‑use pre‑filled pen. The recommendation is based on the phase 3 FRONTIER programme, where denecimig achieved consistently low mean annualised bleeding rates, generally below 1, with many participants having zero treated bleeds, and no new safety signals on switching from emicizumab. Novo expects initial launches in select European countries in Q4 2026 and broader EU rollout from early 2027, pending final EMA approval.
Positive
- CHMP positive opinion recommending EU marketing authorisation for FREHEMGO in haemophilia A with or without inhibitors, in adults and children
- Flexible dosing with once‑monthly, once‑every‑two‑weeks and once‑weekly prophylaxis in a single‑use pre‑filled pen
- Phase 3 FRONTIER data show mean annualised bleeding rates generally below 1 and many patients with zero treated bleeds
- Switching study found no new safety signals after direct switch from emicizumab and showed clear device preference for denecimig
- Commercial timing anticipated EU launches starting Q4 2026 and broader rollout from early 2027, subject to approval
Negative
- FREHEMGO remains pending marketing approval from the EMA and other regulatory authorities, so regulatory risk persists
- There is no disclosed revenue or pricing guidance for FREHEMGO, leaving the financial impact unspecified
AI-generated analysis. How Rhea-AI works. Not financial advice.
- FREHEMGO® (denecimig) has been recommended by CHMP for approval in the EU for the treatment of haemophilia A (congenital FVIII deficiency), with or without inhibitors for 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 expects to launch FREHEMGO® in the first European countries in Q4 2026 and broadly across the EU starting early 2027
Bagsværd, Denmark, 17 September 2026 – Novo Nordisk today 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) to treat haemophilia A (HA), with or without inhibitors, in adults and children.
FREHEMGO® is a next-generation factor VIIIa mimetic bispecific antibody, designed as a routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people living with HA, with or without inhibitors.
The CHMP recommendation is based on the FRONTIER trial programme. In the pivotal FRONTIER 2 trial, denecimig significantly reduced annualised bleeding rate compared to prior clotting factor prophylaxis and on-demand treatment in people with HA, with or without inhibitors. In children younger than 12 years, results from FRONTIER 3 were consistent with the efficacy observed in adolescents and adults.1-2 Across the FRONTIER programme, denecimig has demonstrated consistently low mean annualised bleeding rates, generally below 1 in the reported phase 3 population, and with a substantial proportion of participants experiencing zero treated bleeds.1-3 Furthermore, in the FRONTIER 5 trial, no new safety signals were identified following direct switching from emicizumab to denecimig prophylaxis. The study also showed a clear preference for the denecimig device.4
“The recommendation by the CHMP for approval of FREHEMGO® builds on Novo’s commitment of over 40 years in haemophilia and marks an important advancement for people living with haemophilia A, with or without inhibitors”, said Mike Doustdar, president and CEO of Novo. “The combination of strong bleed protection, flexible dosing frequency and a prefilled pen offers a differentiated treatment option that can reduce treatment burden and give people with haemophilia A greater freedom in managing their disease.”
In September 2025, Novo submitted denecimig for review to the US Food and Drug Administration (FDA) through a Biologics License Application (BLA).
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.
Novo is the global healthcare company that believes lasting health starts now. For over a century, we’ve combined leading scientific expertise with a deep understanding of people’s lives. We develop treatments and support that help millions of people make progress they can see, feel and sustain now and in the future. Every day, over 67,000 employees around the world advance our purpose to drive change for lasting health. Through our partnerships, programmes and investments, we’re working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com and follow us on Instagram, LinkedIn, TikTok, Facebook, X and YouTube.
Publication of inside information pursuant to Market Abuse Regulation, Article 17.
Contacts for further information
| Novo Media: | |
| Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com | Liz Skrbkova (US) +1 609 917 0632 USMediaRelations@novonordisk.com |
| Novo Investors: | |
| Michael Novod +45 3075 6050 nvno@novonordisk.com | Sina Meyer +45 3079 6656 azey@novonordisk.com |
| Christoffer Togo Solgaard-Tullin +45 3079 1471 cftu@novonordisk.com | |
| Ida Schaap Melvold +45 3077 5649 idmg@novonordisk.com | Mads Berner Bruun +45 3075 2936 mbbz@novonordisk.com |
| Frederik Taylor Pitter (US) +1 609 613 0568 fptr@novonordisk.com | Alex Bruce (US) +1 640 230 0276 axeu@novonordisk.com |
Company announcement No 55 / 2026
1 NCT5053139; Mancuso ME, Chan AKC, Shanmukhaiah C, et al. N Engl J Med. 2026; doi: 10.1056/NEJMoa2517384
2 NCT05306418
3 NCT05685238
4 NCT05878938; Hermans C, Benson G, Matino D, et al. J Thromb Haemost. 2026; doi: 10.1016/j.jtha.2026.09.004
Attachment
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is FREHEMGO (denecimig) and how does it work in haemophilia A?
FREHEMGO (denecimig) is an FVIIIa mimetic bispecific antibody administered under the skin for people with haemophilia A, with or without inhibitors. It is designed to ‘mimic’ the role of activated factor VIII (FVIIIa) by bridging factor IXa and factor X. This action mimics the cofactor function of FVIIIa and helps restore the body’s thrombin generation capacity, supporting blood clot formation and aiming to prevent or reduce bleeding episodes.
Which FRONTIER trials supported the marketing application for denecimig?
The denecimig Marketing Authorisation Application was based on FRONTIER2, FRONTIER3 and FRONTIER4. FRONTIER2 evaluated once‑monthly and once‑weekly denecimig in adults and adolescents aged 12 years and older. FRONTIER3 evaluated once‑monthly and once‑weekly dosing in children under 12 years. FRONTIER4 was an open‑label extension assessing once‑every‑two‑weeks dosing and long‑term safety across all regimens (monthly, every two weeks and weekly) in people with haemophilia A, with or without inhibitors.
What were the key findings from the pivotal FRONTIER 2 and FRONTIER 3 trials?
In the pivotal FRONTIER 2 trial, denecimig significantly reduced annualised bleeding rate compared with prior clotting factor prophylaxis and on‑demand treatment in people with haemophilia A, with or without inhibitors. In children younger than 12 years, FRONTIER 3 results were consistent with the efficacy observed in adolescents and adults, supporting similar bleed protection across age groups.
What did the FRONTIER 5 trial show about switching from emicizumab to denecimig?
FRONTIER 5 evaluated people with haemophilia A who switched directly from emicizumab to denecimig prophylaxis. The trial identified no new safety signals after the switch and also reported a clear preference among participants for the denecimig device.
What is the regulatory status of denecimig outside the European Union?
Beyond the European Union, Novo Nordisk submitted a Biologics License Application for denecimig to the US Food and Drug Administration in September 2025. FREHEMGO is described as pending marketing approval from the EMA and other regulatory authorities.
What populations with haemophilia A is FREHEMGO intended to treat?
FREHEMGO is intended as a routine prophylactic treatment to prevent or reduce bleeding episodes in people living with haemophilia A, both adults and children, and includes individuals with or without factor VIII inhibitors.