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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: crovalimab-akkz
Trade Name: Piasky
Date Designated: 09/05/2017
Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria (PNH)
Orphan Designation Status: Designated/Approved
Genentech Inc.
1 DNA Way
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: crovalimab-akkz
Trade Name: Piasky
Marketing Approval Date: 06/20/2024
Approved Labeled Indication: treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg
Exclusivity End Date: 06/20/2031 
Exclusivity Protected Indication* :  treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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