antihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl
Trade name: ALTUVIIIO
Recombinant proteinapprovedOrphan Drug FDA
Approved
Feb 22, 2023
Clinical trial activity
0 trials · 0 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0
Timeline
2010s
- Aug 3, 2017
Orphan Drug Designation
2020s
- Feb 22, 2023
Sanofi-Aventis — Earliest FDA Approval
- Feb 22, 2023
Sanofi-Aventis — NDA Secondary Org
- Feb 22, 2023
Sanofi-Aventis — NDA Organization
Indications
Approved for
Mechanism of action
- Coagulation factor VIIISupplementation
F8 supplementation
Approval history
- approvedFeb 22, 2023
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Organizations
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Sanofi-Aventis | For profit | NDA2 | Feb 22, 2023 |
| Sanofi-Aventis | For profit | NDA | Feb 22, 2023 |