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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: burosumab-twza
Trade Name: Crysvita
Date Designated: 12/14/2009
Orphan Designation: Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)
Orphan Designation Status: Designated/Approved
Kyowa Kirin, Inc.
135 US Highway 202/206
Suite 6
Bedminster, New Jersey 07921
United States

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

Marketing approved:

1 Generic Name: burosumab-twza
Trade Name: Crysvita
Marketing Approval Date: 04/17/2018
Approved Labeled Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
Exclusivity End Date: 04/17/2025 
Exclusivity Protected Indication* :  CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
2 Generic Name: burosumab-twza
Trade Name: Crysvita
Marketing Approval Date: 09/27/2019
Approved Labeled Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
Exclusivity End Date: 09/27/2026 
Exclusivity Protected Indication* :  For the treatment of X-linked hypophosphatemia (XLH) in pediatric patients 6 months of age to less than 1 year of age
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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