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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a protein based on human alpha-1-antitrypsin (a1AT) with three mutations in the reactive center loop (RCL) conferring specificity for APC over other plasma proteases
Date Designated: 09/13/2022
Orphan Designation: Treatment of Hemophilia B
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
ApcinteX Limited
3rd Floor 1 Ashley Road
Altrincham, Cheshire Wa14 2dt
United Kingdom

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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