Frehemgo

Opinion

EMA has issued an opinion on this medicine

denecimig

Overview

On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Frehemgo, intended for routine prophylaxis of bleeding episodes in patients with haemophilia A.

The applicant for this medicinal product is Novo Nordisk A/S.

Frehemgo will be available as 1.6 mg, 4 mg, 9 mg, 20 mg and 46 mg solution for injection in pre-filled pen. The active substance of Frehemgo is denecimig, an antihaemorrhagic (ATC code: B02BX13). Denecimig is a fully human modified immunoglobulin G4 antibody that acts as a mimetic of activated factor VIII (FVIII). It bridges activated coagulation factor IX (FIXa) and coagulation factor X (FX) on the surface of activated platelets, thereby promoting the generation of activated FXa. 

The benefit of Frehemgo is its ability to reduce bleeding events in children, adolescents and adults with haemophilia A. The most common side effects with Frehemgo are injection site reactions, prothrombin fragment 1.2 increased and fibrin D dimer increased.

The full indication is:

FREHEMGO is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency):

• with FVIII inhibitors
• without FVIII inhibitors who have,
  • severe disease (FVIII < 1%)
  • moderate disease (FVIII ≥ 1% and ≤ 5%) requiring prophylaxis treatment.

This medicinal product can be used in all age groups.

Treatment must be initiated under the supervision of a physician experienced in the management of haemophilia and/or bleeding disorders. 

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Frehemgo

Adopted Reference Number: EMADOC-1829012207-71075

Product details

• Name of medicine:
  Frehemgo
• Active substance:
  denecimig
• International non-proprietary name (INN) or common name:
  denecimig
• Therapeutic area (MeSH):
  Hemophilia A
• EMA product number:
  EMEA/H/C/006344
• Marketing authorisation applicant:
  Novo Nordisk A/S
• Opinion adopted:
  17/09/2026
• Opinion status:
  Positive