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Crysvita Approval History

FDA Approved: Yes (First approved April 17, 2018)
Brand name: Crysvita
Generic name: burosumab-twza
Dosage form: Injection
Company: Ultragenyx Pharmaceutical Inc.
Treatment for: X-Linked Hypophosphatemia

Crysvita (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody for the treatment of x-linked hypophosphatemia (XLH).

Development History and FDA Approval Process for Crysvita

DateArticle
Apr 17, 2018Approval FDA Approves Crysvita (burosumab-twza) for X-Linked Hypophosphatemia
Oct 10, 2017Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab Biologics License Application
Aug 24, 2017Ultragenyx and Kyowa Hakko Kirin Announce Submission of Burosumab Biologics License Application in the US

Further information

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