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Refixia
Published
Product name
Refixia
Active ingredient
Nonacog beta pegol
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Refixia (nonacog beta pegol) was approved for the following therapeutic use:
Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).
How this medicine works
Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) conjugated to the protein. Patients with haemophilia B are deficient in coagulation factor IX, which is required for effective haemostasis. The administration of Refixia increases plasma levels of factor IX and can temporarily correct the coagulation defect in haemophilia B patients. Factor IX is activated by factor XIa and by factor VII/tissue factor complex. Upon activation of Refixia, the activation peptide including the 40 kDa polyethylene-glycol moiety is cleaved off, leaving the native factor IX molecule. Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot is formed.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Refixia was considered favourable for the therapeutic use approved.