Regulatory Decision Summary for ELOCTATE
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
Eloctate is currently approved for use in adults and children (≥12 years) with hemophilia A (congenital factor VIII deficiency) for routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes and for the control and prevention of bleeding episodes. The purpose of this submission is to extend the use of Eloctate to children less than 12 years of age and to use in perioperative management for all age groups. Clinical trial data are not yet available for use in previously untreated patients (PUPs).
Why was the decision issued?
Eloctate is a recombinant B domain deleted Factor VIII Fc Fusion Protein. Binding of rFVIII to the Fc fragment of IgG1 decreases the clearance and increases the half-life of the FVIII activity. The benefit of this is a decrease in the frequency of injections needed for prophylaxis of bleeding episodes in patients with Hemophilia A. Prophylactic treatment is considered standard of care to prevent the damage to tissues, particularly joints, which occurs spontaneously or from trauma. For some patients there could be a decreased frequency of FVIII infusions to as few as twice a week which could lead to improved compliance which is particularly important at young ages to prevent early joint damage.
Surgeons have rated control of bleeding in surgery as excellent or good. The increased half-life may decrease the number of infusions needed perioperatively.
No new safety issues have been associated with the use of Eloctate to date in the ≥12 years of age population. Inhibitor formation and hypersensitivity reactions were reported but these are known to occur with FVIII replacement. Safety update reports will continue to be submitted to the Marketed Health Product Directorate (MHPD) as the product continues to be marketed with the new indications.
Factor VIII replacement is essential to prevent and treat bleeding in patients with Hemophilia A. The risk associated with Eloctate is not different from other FVIII replacement products on the market. A decrease in the frequency of infusions has the potential to provide benefit. There is a favourable benefit-risk profile.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.