ALTUVIIIO
STN: 125771
Proper Name: antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
Tradename: ALTUVIIIO
Manufacturer: Bioverativ Therapeutics Inc.
Indication:
- For use in adults and children with hemophilia A (congenital factor VIII deficiency) for:
- Routine prophylaxis to reduce the frequency of bleeding episodes
- On-demand treatment & control of bleeding episodes
- Perioperative management of bleeding.
- ALTUVIIIO is not indicated for the treatment of von Willebrand disease.
Product Information
Supporting Documents
- May 10, 2024 Approval Letter - ALTUVIIIO
- May 7,2024 Statistical Review - ALTUVIIIO
- May 7, 2024 Clinical Review Memo- ALTUVIIIO
- February 22, 2023 Approval Letter - ALTUVIIIO
- February 22, 2023 Approval Replacement Letter - ALTUVIIIO
- February 21, 2023 Summary Basis for Regulatory Action - ALTUVIIIO
- Approval History, Letters, Reviews, and Related Documents - ALTUVIIIO