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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
Trade Name: Altuviiio
Date Designated: 08/03/2017
Orphan Designation: Treatment of hemophilia A
Orphan Designation Status: Designated/Approved
Bioverativ Therapeutics, Inc.
225 Second Avenue
Waltham, Massachusetts 02451
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
Trade Name: Altuviiio
Marketing Approval Date: 02/22/2023
Approved Labeled Indication: 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
Exclusivity End Date: 02/22/2030 
Exclusivity Protected Indication* :  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
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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