Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: Inotersen
Trade Name: TEGSEDI™
Date Designated: 07/24/2012
Orphan Designation: Treatment of transthyretin amyloidosis (ATTR amyloidosis)
Orphan Designation Status: Designated/Approved
Akcea Therapeutics, Inc.
22 Boston Wharf Road
9th Floor
Boston , Massachusetts 02210
United States

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

Marketing approved:

1 Generic Name: Inotersen
Trade Name: TEGSEDI™
Marketing Approval Date: 10/05/2018
Approved Labeled Indication: TEGSEDI¿ is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Exclusivity End Date: 10/05/2025 
Exclusivity Protected Indication* :  TEGSEDI¿ is indicated for the 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-