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Alhemo
Published
Product name
Alhemo
Active ingredient
Concizumab
Submission type
New Biological Entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Alhemo (concizumab) was approved for the following therapeutic use:
Alhemo is indicated where prophylaxis is required to prevent or reduce the frequency of bleeding in patients at least 12 years of age who have haemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors.
How this medicine works
Concizumab is an antibody against tissue factor pathway inhibitor (TFPI). Physiologically, TFPI dampens the initiation of coagulation by reducing formation of, and directly inhibiting, activated factor X (FXa). Concizumab binds to the Kunitz 2 (K2) domain of TFPI and inhibits these actions of TFPI. For patients with haemophilia, who have inadequate propagation of coagulation due to deficiency of factor VIII (FVIII) or factor IX (FIX), removing TFPI inhibition may allow adequate formation of FXa to generate sufficient thrombin for haemostasis.
As concizumab acts independently from FVIII and FIX, the effect of concizumab is not expected to be influenced by the presence of inhibitory antibodies to FVIII or FIX.
As concizumab has no structural relationship or sequence homology to FVIII or FIX, it is not expected to induce or enhance the development of direct inhibitors to FVIII or FIX.
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 Alhemo was considered favourable for the therapeutic use approved.
ARTG details
- ALHEMO concizumab 60 mg / 1.5 mL solution for injection prefilled pen (394065)
- ALHEMO concizumab 150mg / 1.5 mL solution for injection prefilled pen (394067)
- ALHEMO concizumab 15 mg / 1.5 mL solution for injection prefilled pen (394068)
- ALHEMO concizumab 300 mg / 3 mL solution for injection prefilled pen (394066)