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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: eplontersen
Trade Name: Wainua
Date Designated: 01/06/2022
Orphan Designation: Treatment of transthyretin-mediated amyloidosis
Orphan Designation Status: Designated/Approved
Ionis Pharmaceuticals, Inc.
2855 Gazelle Ct
Carlsbad, California 92010
United States

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

Marketing approved:

1 Generic Name: eplontersen
Trade Name: Wainua
Marketing Approval Date: 12/21/2023
Approved Labeled Indication: Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Exclusivity End Date: 12/21/2030 
Exclusivity Protected Indication* :  Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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