OBIZUR (susoctogog alfa), porcine recombinant factor VIII

No clinical benefit demonstrated in current treatment of severe bleeding in patients with acquired haemophilia

• OBIZUR has Marketing Authorisation only in the treatment of bleeding episodes in patients with acquired haemophilia due to factor VIII antibodies.
• Laboratory monitoring of its efficacy is possible, based on the measurement of FVIII activity, in addition to clinical monitoring.
• Clinical efficacy data are limited and the safety profile is poorly documented. There is no clinical information on the development of anti-OBIZUR inhibitor antibodies after repeated administration, the main risk related to the treatment.