STN: 125771
Proper Name: antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
Tradename: ALTUVIIIO
Manufacturer: Bioverativ Therapeutics Inc., a Sanofi Company
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 and control of bleeding episodes; and
- Perioperative management of bleeding.
Product Information
Supporting Documents
- March 7, 2025 Approval Letter – ALTUVIIIO
- 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
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Content current as of:
03/12/2025
