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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mitapivat
Trade Name: Pyrukynd
Date Designated: 03/24/2015
Orphan Designation: Treatment of pyruvate kinase deficiency
Orphan Designation Status: Designated/Approved
Agios Pharmaceuticals, Inc.
88 Sidney Street
Cambridge, Massachusetts 02139
United States

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

Marketing approved:

1 Generic Name: mitapivat
Trade Name: Pyrukynd
Marketing Approval Date: 02/17/2022
Approved Labeled Indication: Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
Exclusivity End Date: 02/17/2029 
Exclusivity Protected Indication* :  Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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