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ALTUVIIIO (Sanofi-Aventis Australia Pty Ltd)
Product name
ALTUVIIIO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
190 (255 working days)
Active ingredients
efanesoctocog alfa
Registration type
NCE/NBE
Indication
ALTUVIIIO is a long-acting recombinant anti-haemophilic factor (coagulation FVIII) indicated in adults, adolescents and children with haemophilia A (congenital FVIII deficiency) for:
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- Treatment and control of bleeding episodes
- Perioperative management of bleeding (surgical prophylaxis)
ALTUVIIIO does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand’s disease.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.